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{{#Wiki_filter:FINAL Supporting Statement, 10 CFR Part 26 Description of Data ElementValueUnit FFD Drug & Alcohol (D&A) Testing Programs28FFD programD&A testing programs26FFD program Reactor Construction Site D&A testing programs2FFD program Number of Sites covered by an FFD D&A Testing Program69siteOperating Reactors59siteReactors under Construction2siteV.C. Summer (Units 2&3); Vogtle (Units 3&4)Corporate Offices5site Duke, Exelon, Southern, TVA, and XcelFuel Cycle Facilities2site B&W, NFSContractor/Vendor (C/V)1site INPO Drug Testing LaboratoriesLicensee Testing Facilities (LTFs)6LTFHHS-certified laboratories (HHS labs)9HHS lab Laboratory Testing 67Number of sites using an LTF6LTF Number of sites only using an HHS-lab61HHS lab D&A Testing Program DataD&A PgrmConstructionTotalTotal Tests (all Reasons For Testing) 146,83112,674159,505Pre-access81,2196,89888,117 Random57,4764,65362,128 For Cause405243648 Post Event480375855 Followup7,2505057,756Total Individuals with D&A testing violations (all Test Types)8262531,079Pre-access568147715 Random14461205 For Cause563288 Post Event4712 Followup54660Total Testing violations (by results)D&A PgrmConstructionTotalNumber of drug & alcohol positive, adulterated, substituted, and refusal to test results8262531,079Number of drug only positive , adulterated, substituted, and refusal to test results621217838D&A PgrmConstruction103,9337,634 Number of Reportable Events per Year (average 2013-2015)20132014201524-hour reports under 26.719(b)37report26.719(b) hour event reports403833 30-day reports under 26.719(c)8report26.719(c) day event reports1653 10 CFR 170.20 Average Cost per Professional Hour (2017)$265hourly ratePrevious clearance = $272/hour Fatigue management programs21programFFD program performance data (2015)
{{#Wiki_filter:FINAL Supporting Statement, 10 CFR Part 26 Description of Data Element                                      Value        Unit                Data Source FFD Drug & Alcohol (D&A) Testing Programs                          28      FFD program D&A testing programs                                            26      FFD program              FFD program performance data (2015)
Individuals subject to a random D&A testing program FFD program performance data (2013-2015)
Reactor Construction Site D&A testing programs                  2      FFD program Number of Sites covered by an FFD D&A Testing Program              69          site                2015 FFD program performance data Excludes DECON sites (Crystal River, Fort Calhoun, Kewaunee, San Operating Reactors                                              59          site Onofre, Vermont Yankee)
Data Source FFD program performance data (2015) 2015 FFD program performance data Excludes DECON sites (Crystal River, Fort Calhoun, Kewaunee, San Onofre, Vermont Yankee)
Reactors under Construction                                      2          site                V.C. Summer (Units 2&3); Vogtle (Units 3&4)
FFD program performance data (2015)
Corporate Offices                                                5          site                Duke, Exelon, Southern, TVA, and Xcel Fuel Cycle Facilities                                            2          site                B&W, NFS Contractor/Vendor (C/V)                                         1          site                INPO Drug Testing Laboratories Licensee Testing Facilities (LTFs)                               6          LTF                  FFD program performance data (2015)
FFD program performance data (2015)
HHS-certified laboratories (HHS labs)                           9        HHS lab Laboratory Testing                                                 67 Number of sites using an LTF                                    6          LTF                  FFD program performance data (2015)
FFD program performance data (average of 2013-2015)
Number of sites only using an HHS-lab                          61        HHS lab D&A Testing Program Data                                        D&A Pgrm Construction        Total Total Tests (all Reasons For Testing)                           146,831        12,674  159,505 Pre-access                                                    81,219          6,898  88,117 Random                                                        57,476          4,653  62,128 FFD program performance data (average of 2013-2015)
FFD program performance data (average of 2013-2015)
For Cause                                                        405          243      648 Post Event                                                        480          375      855 Followup                                                        7,250          505    7,756 Total Individuals with D&A testing violations (all Test Types)       826          253    1,079 Pre-access                                                        568          147      715 Random                                                            144            61      205 FFD program performance data (average of 2013-2015)
FFD program performance data (average of 2013-2015)
For Cause                                                          56            32      88 Post Event                                                          4              7      12 Followup                                                          54              6      60 Total Testing violations (by results)                         D&A Pgrm Construction        Total Number of drug & alcohol positive, adulterated,                     826          253    1,079 substituted, and refusal to test results                                                        FFD program performance data (average of 2013-2015)
Page 1 of 24 FINAL Supporting Statement, 10 CFR Part 26TestedPositiveTestedPositiveTestedPositiveTestedPositiveTestedPositiveTotal TestsTotal +All Sites90,04972864,37421265890877127,93661163,8951,102247Construction sites6,8981474,65361243323757505612,67425337217DECON sites1,932132,246710222018114,390236Sites w/o Construction & DECON81,21956857,4761444055648047,25054146,831826205621 Results b y Yea r Summary Results
Number of drug only positive, adulterated,                         621          217      838 substituted, and refusal to test results D&A Pgrm Construction Individuals subject to a random D&A testing program                                                  FFD program performance data (2013-2015) 103,933          7,634 Number of Reportable Events per Year (average 2013-2015)                                                                                               2013 2014 2015 24-hour reports under 26.719(b)                                 37        report                                26.719(b) hour event reports    40  38  33 30-day reports under 26.719(c)                                   8        report                                26.719(c) day event reports    16    5    3 10 CFR 170.20 Average Cost per Professional Hour (2017)           $265      hourly rate            Previous clearance = $272/hour Fatigue management programs                                        21        program               FFD program performance data (2015)
Page 1 of 24


2015TestedPositiveTestedPositiveTestedPositiveTestedPositiveTestedPositiveTotal TestsTotal +All Sites88,59379064,7552256541061,016178,38060163,3981,198248Construction sites6,3951306,179862764953513703914,08828735DECON sites2,014161,55654118010813,700234Sites w/o Construction & DECON80,18464457,0201343745646347,56950145,610888209679 Summary Results 2014TestedPositiveTestedPositiveTestedPositiveTestedPositiveTestedPositiveTotal TestsTotal +All Sites92,36876264,68922169483897137,94254166,5901,133255Construction sites8,4141914,95763266333927510114,53929546DECON sites1,24341,9941110416015403,417198Sites w/o Construction & DECON82,71156757,7381474184648967,27853148,634819201618 Summary Results 2013TestedPositiveTestedPositiveTestedPositiveTestedPositiveTestedPositiveTotal TestsTotal +All Sites89,18763163,6781906278071857,48769161,697975238Construction sites5,8861202,8223418615197230379,39417829DECON sites2,538193,187617032028026,054275Sites w/o Construction & DECON80,76349257,6691504246548936,90460146,249770204566 Summary Results 2012TestedPositiveTestedPositiveTestedPositiveTestedPositiveTestedPositiveTotal TestsTotal +All Sites101,43876567,9432057248688378,14750179,1351,113255Construction sites4,6751022,8193123714157227648,16415325DECON sites2,873123,402830324037226,701257Sites w/o Construction & DECON93,89065161,7221664576970257,49944164,270935223712RandomFor CausePost-EventFollowupPre-AccessRandomFor CausePost-EventFollowupPre-AccessRandomFor CausePost-EventFollowup Total Results without Alcohol Total Results without Alcohol Alcohol Totals Alcohol Totals Alcohol Totals Alcohol Totals Alcohol Totals Average Results (2013-2015)
FINAL Supporting Statement, 10 CFR Part 26 FFD program performance data (2012-2015) - 2012 data used in previous clearance; 2013-2015 used in current clearance Pre-Access          Random          For Cause      Post-Event      Followup                        Alcohol  Total Results Average Results (2013-2015)
FFD program performance data (2012-2015) - 2012 data used in previous clearance; 2013-2015 used in current clearance Total Results without Alcohol Total Results without Alcohol Total Results without AlcoholPre-AccessRandomFor CausePost-EventFollowupPre-AccessRandomFor CausePost-EventFollowup Pre-Access Page 2 of 24 FINAL Supporting Statement, 10 CFR Part 26 FFD program performance data (2012-2015) - 2012 data used in previous clearance; 2013-2015 used in current clearance Average Population Subject to Random Testing2012201320142015 Average 2013-2015 All Sites123,278115,532115,709115,254 115,498 All sites (w/o Construction & DECON) 112,732104,728104,037103,033 103,933 CONSTRUCTIONV.C. Summer Units 2 and 31,6421,9503,0643,802 Vogtle Units 3 and 42,7363,0995,0375,9504,3785,0498,1019,7527,634 DECOMMISSIONINGCrystal River1,544922592392 Fort Calhoun1,4411,2041,184 Kewaunee829495295205 San Onofre2,9341,899723688 Vermont Yankee8619987570<< Is not reporting data since ceasing operations at the end of 2014Total6,1685,7553,5712,4693,932 Alcohol Positive Results2012201320142015Total All Sites255238255248 Total All Sites w/o Construction & DECON223204201209
Tested  Positive Tested Positive  Tested Positive Tested Positive Tested Positive Total Tests Total + Totals  without Alcohol All Sites  90,049      728 64,374    212        658    90  877        12 7,936        61  163,895 1,102        247 Construction sites    6,898      147  4,653      61        243    32  375        7    505        6    12,674    253      37        217 DECON sites      1,932        13  2,246      7        10      2    22        0    181        1      4,390      23      6 Sites w/o Construction & DECON      81,219      568 57,476    144        405    56  480        4 7,250        54  146,831      826    205      621 Results by Year Summary Results                                 Pre-Access          Random          For Cause      Post-Event      Followup                        Alcohol  Total Results 2015                                          Tested  Positive Tested Positive  Tested Positive Tested Positive Tested Positive Total Tests Total + Totals  without Alcohol All Sites  88,593      790 64,755    225        654    106 1,016        17 8,380        60  163,398 1,198        248 Construction sites    6,395      130  6,179      86        276    49  535        13    703        9    14,088    287      35 DECON sites      2,014        16  1,556      5          4    1    18        0    108        1      3,700      23      4 Sites w/o Construction & DECON      80,184      644 57,020    134        374    56  463        4 7,569        50  145,610      888    209      679 Summary Results                                 Pre-Access          Random          For Cause      Post-Event      Followup                        Alcohol  Total Results 2014                                          Tested  Positive Tested Positive  Tested Positive Tested Positive Tested Positive Total Tests Total + Totals  without Alcohol All Sites  92,368      762 64,689    221        694    83  897        13 7,942        54  166,590 1,133        255 Construction sites    8,414      191  4,957      63        266    33  392        7    510        1    14,539    295      46 DECON sites      1,243          4  1,994      11        10      4    16        0    154        0      3,417      19      8 Sites w/o Construction & DECON      82,711      567 57,738    147        418    46  489        6 7,278        53  148,634      819    201      618 Summary Results                                 Pre-Access          Random          For Cause      Post-Event      Followup                        Alcohol  Total Results 2013                                          Tested  Positive Tested Positive  Tested Positive Tested Positive Tested Positive Total Tests Total + Totals  without Alcohol All Sites  89,187      631 63,678    190        627    80  718        5 7,487        69  161,697      975    238 Construction sites    5,886      120  2,822      34        186    15  197        2    303        7      9,394    178      29 DECON sites      2,538        19  3,187      6        17      0    32        0    280        2      6,054      27      5 Sites w/o Construction & DECON      80,763      492 57,669    150        424    65  489        3 6,904        60  146,249      770    204      566 Summary Results                                  Pre-Access          Random          For Cause      Post-Event      Followup                        Alcohol Total Results 2012                                           Tested  Positive Tested Positive  Tested Positive Tested Positive Tested Positive Total Tests Total + Totals  without Alcohol All Sites 101,438      765 67,943    205        724    86  883        7 8,147        50  179,135 1,113        255 Construction sites     4,675      102  2,819      31        237    14  157        2    276        4      8,164    153      25 DECON sites      2,873        12  3,402      8        30      3     24        0    372        2      6,701      25      7 Sites w/o Construction & DECON      93,890      651 61,722    166        457    69  702        5 7,499        44  164,270      935    223      712 Page 2 of 24


CONSTRUCTIONV.C. Summer Units 2 and 310182118 Vogtle Units 3 and 415112517Total25294635 DECOMMISSIONINGCrystal River0030 Fort Calhoun0314 Kewaunee2020 San Onofre1000 Vermont Yankee4220Total7584 HHS-Certified Labs Performing Testing for Part 26 Licensees & Other Entities2014 OMB Clearance (used 2012 FFD program performance data)2017 OMB Clearance (used 2015 FFD program performance data)1Alere Toxicology1Alere Toxicology (Gretna, LA) 2Clinical Reference Lab (Lenexa, KS)2Clinical Reference Lab (Lenexa, KS) 3Drug Scan (Horsham, PA)3Drug Scan (Horsham, PA) 4Laboratory Corporation of America (RTP, NC)4Laboratory Corporation of America (RTP, NC) 5Laboratory Corporation of America5MedTox Laboratories (St. Paul, MN) 6MedTox Laboratories (St. Paul, MN)6Quest Diagnostics (Lenexa, KS) 7Quest Diagnostics (Lenexa, KS)7Quest Diagnostics (Norristown, PA) 8Quest Diagnostics (Norristown, PA)8Quest Diagnostics (Atlanta, GA) 9Quest Diagnostics (Tucker, GA)9Southwest Laboratories (Phoenix, AZ)10Quest Diagnostics (Atlanta, GA) 11Southwest Laboratories (Phoenix, AZ) 12not specified in hardcopy report Page 3 of 24 FINAL Supporting Statement, 10 CFR Part 26 Index Key:- Updated- Duplicative
FINAL Supporting Statement, 10 CFR Part 26 FFD program performance data (2012-2015) - 2012 data used in previous clearance; 2013-2015 used in current clearance Average Average Population Subject to Random Testing      2012    2013      2014    2015 2013-2015 All Sites                                    123,278  115,532 115,709 115,254      115,498 All sites (w/o Construction & DECON)         112,732  104,728 104,037 103,033      103,933 CONSTRUCTION V.C. Summer Units 2 and 3                      1,642    1,950    3,064  3,802 Vogtle Units 3 and 4                          2,736    3,099    5,037  5,950 4,378    5,049    8,101  9,752      7,634 DECOMMISSIONING Crystal River                                  1,544      922      592    392 Fort Calhoun                                            1,441    1,204   1,184 Kewaunee                                        829      495      295    205 San Onofre                                    2,934    1,899      723    688 Vermont Yankee                                  861      998      757      0             << Is not reporting data since ceasing operations at the end of 2014 Total    6,168    5,755    3,571   2,469      3,932 Alcohol Positive Results                            2012    2013    2014    2015 Total All Sites                                    255      238      255    248 Total All Sites w/o Construction & DECON          223      204      201    209 CONSTRUCTION V.C. Summer Units 2 and 3                      10      18      21      18 Vogtle Units 3 and 4                           15      11      25      17 Total      25      29       46      35 DECOMMISSIONING Crystal River                                  0        0        3      0 Fort Calhoun                                    0       3        1      4 Kewaunee                                        2        0        2      0 San Onofre                                      1        0        0      0 Vermont Yankee                                  4       2        2     0 Total        7       5        8      4 HHS-Certified Labs Performing Testing for Part 26 Licensees & Other Entities 2014 OMB Clearance (used 2012 FFD program performance data)                     2017 OMB Clearance (used 2015 FFD program performance data) 1 Alere Toxicology                                                              1 Alere Toxicology (Gretna, LA) 2 Clinical Reference Lab (Lenexa, KS)                                           2 Clinical Reference Lab (Lenexa, KS) 3 Drug Scan (Horsham, PA)                                                       3 Drug Scan (Horsham, PA) 4 Laboratory Corporation of America (RTP, NC)                                   4 Laboratory Corporation of America (RTP, NC) 5 Laboratory Corporation of America                                              5 MedTox Laboratories (St. Paul, MN) 6 MedTox Laboratories (St. Paul, MN)                                             6 Quest Diagnostics (Lenexa, KS) 7 Quest Diagnostics (Lenexa, KS)                                                 7 Quest Diagnostics (Norristown, PA) 8 Quest Diagnostics (Norristown, PA)                                             8 Quest Diagnostics (Atlanta, GA) 9 Quest Diagnostics (Tucker, GA)                                                 9 Southwest Laboratories (Phoenix, AZ) 10 Quest Diagnostics (Atlanta, GA) 11 Southwest Laboratories (Phoenix, AZ) 12 not specified in hardcopy report Page 3 of 24
- Moved
- New
- Removed Section Number of Record-keepers  Burden Hrs per Recordkeeper (Annualized)
Total Burden Hrs (Annualized)
Number of Record-keepers Burden Hrs per Recordkeeper (Annualized)
Total Burden Hrs (Annualized) Updated26.27(a): Develop FFD policy statement 0                        107.0                      -   0                         112.0                        -   -                Updated26.27(a): Develop FFD procedures 0                        213.0                      -  0                          212.0                        -  -                Updated26.29(a) and (b): Develop FFD training course and exam 0                          96.3                      -  0                          100.0                        -  -
Moved (to Table 4) 26.29(b): All current staff take FFD exam and FFD exam graded 0                       400.4                     -
Moved to Table 4 (Third-Party Disclosure Burden)
-
Moved (to Table 4) 26.29(c)(2): FFD training for current staff 0                     4,710.7                     -
Moved to Table 4 (Third-Party Disclosure Burden)
-
Updated 26.31(b)(1)(v): Develop behavioral observation program (BOP) procedures Burden accounted for under 26.27 (0 programs) Burden accounted for under 26.27(a)-
NEW 26.31(d)(1)(i)(C): Develop rigorous testing procedures to ensure that the MRO can evaluate the use of substances
 
not included in the NRC-required testing panel (if additional
 
substance testing is performed) Not included in previous clearance Burden accounted for under 26.27(a)
Moved (from Table 2) 26.31(d)(1)(i)(D) and (d)(1)(ii): Documentation of forensic toxicologist review and certification of additional drug(s) to
 
be included in the licensee or other entity's drug testing
 
panel Previously accounted for in Table 2 as Annualized Burden              3.0                              5.3                    16.0 16.0 Duplicative Burden 26.31(d)(1)(iii): Document additional drugs in testing panel 0                            0.3                      -
Burden accounted for in section 26.31(d)(3)(iii)(A) and (d)(3)(iii)(C)
-
Moved (from Table 2) 26.31(d)(3)(iii)(A) and (d)(3)(iii)(C): Documentation of forensic toxicologist review and certification of lower drug
 
testing cutoff levels than specified by Part 26, and
 
inclusion of cutoff levels in the FFD policy and procedures Previously accounted for in Table 2 as Annualized Burden              3.0                              5.3                    16.0 16.0 Updated 26.37(a): Develop a system of files and procedures to protect personal information collected under Part 26 0                            2.7                      -  0                            24.0                        -  -                REMOVED 26.37(b): Obtain signed consent for release of information 0                          98.1                      -
REMOVED[covered by Table 2 - 26.37(b)]
-
Updated 26.39(a) and (b): Develop procedures for the review of a determination that an individual has violated the FFD policy 0                          13.3                      -  0                          120.0                        -  -                Updated26.85(a): Develop urine collector qualification training 0                            5.3                      -  0                            13.3                        -  -                Updated26.85(b): Develop alcohol collector qualification training 0                            5.3                      -  0                              5.3                        -  -
Updated 26.127(a) - (e): Develop LTF procedures for specimen handling and chain-of-custody, assays performed, instrument and test setup, and remedial actions for
 
systems and testing devices 0                          80.0                      -  0                            80.0                        -  -
Updated 26.137(a): Develop LTF procedures for quality assurance/
quality control (QA/QC) program 0                          13.3                      -  0                            13.3                        -  -
Moved (from Table 2) 26.153(e): Record of pre-award inspection of new HHS lab (completed prior to awarding contract for testing services)
Previously accounted for in Table 2 as Annualized Burden              3.0                            13.3                    40.0 40.0 Moved (from Table 2) 26.153(f): Record that Part 26 specified requirements included in a licensee's or other entity's contract with a ne w HHS lab Previously accounted for in Table 2 as Annualized Burden              3.0                            13.3                    40.0 40.0 Updated 26.155(a)(1), (a)(3) - (a)(5); (b),(c), (e), and (f):
Confirm HHS lab personnel qualifications and procedures
 
place pursuant to HHS laboratory certification also meet
 
Part 26 requirements (new HHS lab) 0                            2.7                      -  Burden accounted for under 26.153(e)-
Updated 26.157(a) - (e): Confirm HHS lab procedures in place for accession, receipt, shipment, and testing of specimens
 
pursuant to HHS laboratory certification also meet Part 26
 
requirements (new HHS lab) 0                            2.7                      -  Burden accounted for under 26.153(e)-
Updated 26.159(a), (c), (e), (f): Confirm HHS lab procedures for specimen security, chain of custody, and preservation in
 
place pursuant to HHS laboratory certification
 
requirements also meet Part 26 requirements (new HHS
 
lab) 0                            2.7                      -  Burden accounted for under 26.153(e)-
26.203(a): Prepare fatigue management policy  (In addition to 26.27 burden)            2.0                            7.3                  14.6 0                              7.3                        -  (14.6) 26.203(b): Prepare fatigue management procedures (in addition to 26.27 burden)            2.0                            1.7                    3.4 0                              1.7                        -  (3.4)            26.203(c): Prepare training on fatigue management.            2.0                            2.0                    4.0 0                              2.0                        -  (4.0)            26.205(b): Develop work hour tracking system            2.0                            7.7                  15.4 07.7                                                    -  (15.4)          26.205(c): Develop individual work scheduling system            2.0                            2.0                    4.0 0                              2.0                        -  (4.0)
Updated 26.401(b): Prepare a reactor construction site D&A testing program plan 0                          60.0                      -
Burden accounted for under section 26.403(a) and (b)
-
Updated 26.403(a): Develop FFD policy statement (reactor construction site D&A testing program) 0                        107.0                      -  0                          112.0                        -  -
Moved (to Table 2) 26.403(a): Distribute FFD policy statement to subject individuals (reactor construction site D&A testing program) 0                            5.0                      -  Moved to Table 2-Updated 26.403(b): Develop written FFD procedures (reactor construction site D&A testing program) 0                        213.0                      -  0                          216.0                        -  -
Moved (from Table 2) 26.405(d): Record of testing for specified drugs, adulterants, and alcohol, at Part 26 specified cutoff levels Previously accounted for in Table 2 as Annualized Burden  Burden accounted for under section 26.403(a) -
NEW 26.405(e): Develop specimen collection and D&A testing procedures to protect the donor's privacy, integrity of the
 
specimen, and stringent quality controls to ensure accurate
 
test results Previously accounted for in Table 2 as Annualized Burden Burden accounted for under section 26.403(b)
Extension (2017-2020)
Approved Clearance Values (approved 11/30/14 - ICR 201407-3150-007)
Table 1: One Time Recordkeeping Burden Estimate Change Page 4 of 24 FINAL Supporting Statement, 10 CFR Part 26 Index Key:- Updated- Duplicative
- Moved
- New
- Removed Section Number of Record-keepers  Burden Hrs per Recordkeeper (Annualized)
Total Burden Hrs (Annualized)
Number of Record-keepers Burden Hrs per Recordkeeper (Annualized)
Total Burden Hrs (Annualized)
Extension (2017-2020)
Approved Clearance Values (approved 11/30/14 - ICR 201407-3150-007)
Table 1: One Time Recordkeeping Burden Estimate Change Updated 26.406(a), (b), and (d): Develop a fitness monitoring program (applies if reactor construction site D&A testing
 
program does not conduct random testing) 0                          26.7                      -  0                            40.0                        -  -
Updated 26.406(c): Develop procedures for fitness monitors (applies if reactor construction site D&A testing program
 
does not conduct random testing) 0                          40.0                      -  0                            40.0                        -  -
Updated 26.407: Develop procedures for behavioral observation (reactor construction site D&A testing program) 0                          40.0                      -  0                            40.0                        -  -
NEW 26.411(a): Develop procedures for maintaining a system of files to protect personal information collected under
 
Subpart K of Part 26 Not included in previous clearance 0                            40.0                        -
Updated 26.413: Develop procedures for the review of a determination that an individual violated the FFD policy (reactor construction site D&A testing program) 0                        120.0                      -  0                          120.0                        -  -
Moved (from Table 2) 26.713(g): Documentation on testing for additional drugs as permitted under section 26.31(d)(1), use of more
 
stringent testing cutoff levels as permitted under section
 
26.31(d)(3), or both.
Previously accounted for in Table 2 as Annualized Burden Burden accounted for under section 26.31(d)(1)(i)(D) and (d)(1)(ii), and section 26.31(d)(3)(iii)(A) and (d)(3)(iii)(c) Table 1: Total 41.4                112.0                70.6 Page 5 of 24 Final Supporting Statement, 10 CFR Part 26 Index Key:- New- Updated
- Moved
- Duplicative
- Removed Section Number of Record-keepers Burden Hours per Recordkeeper Total Annual Burden Hours Number of Record-keepers Burden Hours per Record-keeper Total Annual Burden Hours Updated 26.4(j):For personnel granted authorization by a licensee, who are covered by the D&A testing program regulated by a
 
State or Federal agency - (1) record of training that
 
demonstrates section 26.29(a) training requirements met (if
 
not already covered by the program); (2) record of notice of
 
any FFD policy violation          30.5                      2.0            61.0              33.5            2.0              67.0 6.0 Updated 26.27(b): Make FFD policy statement readily available to subject personnel          28.0                      4.0          112.0              26.0          16.0            416.0 304.0            Updated 26.27(c): Updates to FFD policy and procedures          28.0                      8.0          224.0              26.0          80.0        2,080.0 1,856.0        Updated 26.27(d): Provide FFD policy and procedures to NRC for review (performed during periodic inspections)          28.0                      4.0          112.0              26.0            4.0            104.0 (8.0)
Updated 26.29(b): Record of training completion (initial training on FFD policy) and results of comprehensive examination          28.0                      2.0            56.0              26.0        104.1        2,707.3 2,651.3        Updated 26.29(c)(2): Record of training completion (annual refresher training on FFD policy)          28.0                      2.0            56.0              26.0        133.2        3,464.4 3,408.4        26.29(d): Record acceptance of FFD training from other licensees' programs          28.0                      4.0          112.0              26.0            4.0            104.0 (8.0)
Updated 26.31(b)(1)(i): Records of background investigations, credit and criminal history checks, and psychological assessments
 
of checks for performed on individuals designated as FFD
 
personnel          28.0                    17.5          490.0              26.0          16.0            416.0 (74.0)
Duplicative Burden 26.31(b)(1)(v): Record results of behavioral observation for FFD program personnel          28.0                    80.0        2,240.0 Burden accounted for under section 26.189(c)
(2,240.0)        Moved (to Table 1) 26.31(d)(1)(i)(D): Document analysis and certification for testing of drugs not included in the NRC minimum testing
 
panel            2.3                      4.0              9.2  Moved to Table 1 (9.2)
Moved (to Table 1) 26.31(d)(2)(ii):  Document licensee additions to tested drugs            2.3                      8.0            18.4  Moved to Table 1 (18.4)
NEW 26.31(d)(3)(ii): Document LTF technician qualifications to perform validity and drug tests.
Not included in clearance Burden accounted for under section 26.125(b) and (c)
Moved (to Table 1) 26.31(d)(3)(iii)(A): Document more stringent cutoff levels            2.0                      8.0            16.0  Moved to Table 1 (16.0)
Moved (to Table 1) 26.31(d)(3)(iii)(C): Document evaluation and certification of more stringent cutoff levels            2.0                      8.0            16.0  Moved to Table 1 (16.0)
REMOVED 26.31(d)(6): Donor provides written permission to conduct another analysis or test on a specimen              -                        1.0                -
Removed.This is a testing limitation provision and does not have a corresponding recordkeeping or reporting burden.
-
Duplicative Burden 26.33: Behavioral observation records          28.0                  400.0      11,200.0 Burden accounted for under section 26.189(c)
(11,200.0)      Moved (to Table 4) 26.35(a): Employee assistance program (EAP) records          28.0                    16.0          448.0  Moved to Table 4 (44 8.0)
Updated 26.35(c): Record of written waiver of right to privacy from individuals given to the Employee Assistance Program (EAP)          28.0                      2.0            56.0              13.0            2.0              26.0 (30.0)
Updated 26.35(c): Record of EAP disclosure to a licensee or other entity that an individual poses an immediate hazard, or who
 
has waived in writing the right to privacy          14.0                      1.0            14.0              13.0            1.0              13.0 (1.0)
Updated 26.37(b)(1): Record of signed consent from individual to disclose information collected under Part 26 to the
 
individual's representative on an FFD matter          28.0                    40.0        1,120.0              26.0            2.5              64.5 (1,055.5)        Updated 26.37(c): Record of signed release from subject individual to disclose personal information collected under Part 26 to othe r licensees or other entities          28.0                    40.0        1,120.0              26.0          40.0        1,040.0 (80.0)
Updated 26.37(d): FFD management provides records to individual on an FFD violation          28.0                    40.0        1,120.0              26.0          40.0        1,040.0 (80.0)
Duplicative Burden 26.39(a): Maintain procedures for the review of FFD violation determinations          28.0                    40.0        1,120.0 Burden accounted for under section 26.27(c)
(1,120.0)        NEW 26.39(b): D&A testing program provides notice to an individual of the grounds of an FFD policy violation
 
determination and review procedures Not included in clearance              26.0          87.3        2,270.6 2,270.6        Updated 26.39(d): If a review of an FFD violation finds in favor of the individual, the licensee or other entity updates records (delet e or correct information found to be inaccurate)          28.0                    40.0        1,120.0                6.0          16.0              96.0 (1,024.0)        Updated 26.39(e): C/V with a D&A testing program provides review procedures to each individual that has violated the FFD policy              -                        0.5                -                  1.0            0.5                0.5 0.5 26.41(a), (b), and (c): Record of audits Burden accounted for under section 26.41(f)
Burden accounted for under section 26.41(f) and (g)
-              26.41(d): Record of review of C/V audit results          28.0                    40.0        1,120.0              26.0          40.0        1,040.0 (80.0)            26.41(f): Document and report audit results          28.0                    40.0        1,120.0              26.0          40.0        1,040.0 (80.0)
Table 2: Annual Recordkeeping Approved Clearance Values (approved 11/30/14 - ICR 201407-3150-Extension (2017-2020)
Burden Estimate Change Page 6 of 24 Final Supporting Statement, 10 CFR Part 26 Index Key:- New- Updated
- Moved
- Duplicative
- Removed Section Number of Record-keepers Burden Hours per Recordkeeper Total Annual Burden Hours Number of Record-keepers Burden Hours per Record-keeper Total Annual Burden Hours Table 2: Annual Recordkeeping Approved Clearance Values (approved 11/30/14 - ICR 201407-3150-Extension (2017-2020)
Burden Estimate Change Updated 26.41(g): Sharing of audit reports - D&A testing programs may jointly conduct audits or accept audits of C/Vs and HHS
 
labs conducted by other D&A testing programs (if the audit
 
addresses the same services utilized by each program)          28.0                    40.0        1,120.0              26.0          40.0        1,040.0 (80.0)
Updated 26.53(e)(2): Record that C/Vs informed licensee of the denial or termination of an individual's authorization            1.0                  120.0          120.0                1.0          13.0              13.0 (107.0) 26.53(g): Record that CVs and other licensees informed of Part 26 violations            7.0                      8.0            56.0  0          8.0                  -  (56.0)
Updated 26.53(h): Obtain and retain written consent from each individual before initiating any actions under Subpart C of
 
Part 26          28.0              1,677.0      46,956.0              26.0        156.2        4,061.0 (42,895.0)      Updated 26.53(i): Individual applying for authorization is informed in writing of the reason(s) for denial or termination of
 
authorization          28.0                    23.3          652.4              26.0          21.8            567.7 (84.7)
Updated 26.55(a)(1) - (a)(2): Initial authorization 26.57(a)(1) - (a)(2): Authorization update
 
26.59(a)(1) - (a)(2): Authorization reinstatement
 
For each individual applying for authorization, a record of a
 
completed self-disclosure, employment history, and suitable
 
inquiry is maintained Burden accounted for under sections 26.61 and 26.63 Burden accounted for under sections 26.61(a), (a)(1), and (a)(2), and 26.63 (a), (c), and (e)
-
Updated 26.59(c)(1): Obtain, review, and retain an applicant's self-disclosure Burden accounted for under section 26.61 Burden accounted for under section 26.61(a), (a)(1) and (a)(2)
-
Updated 26.61(a), (a)(1), and (a)(2): Obtain, review, and retain an applicant's written self-disclosure and employment history          28.0              1,197.0      33,516.0              26.0    1,561.9      40,609.7 7,093.7        NEW 26.61(b) and (c): Specify the information to be collected in the self-disclosure and employment history Not included in clearance Burden accounted for under section 26.61(a), (a)(1) and (a)(2)
Updated 26.63(a), (c), and (e): Obtain, review, and retain an applicant's suitable inquiry          28.0              1,197.0      33,516.0              26.0    1,561.9      40,609.7 7,093.7        Updated 26.63(c)(2): Obtain, review, and retain information on an applicant's U.S. military service (i.e., form DD 214)          28.0                      4.0          112.0              26.0            4.0            104.0 (8.0)
Updated 26.63(c)(3): Document inability to obtain information from an applicant's past employer(s)          28.0                      2.7            75.6              26.0            3.0              78.0 2.4 26.63(d) and (e): Maintain documentation of denial or unfavorable termination of authorization from other FFD
 
programs          28.0                      1.0            28.0              26.0            1.0              26.0 (2.0)
NEW 26.63(f): Specifies the time periods that a suitable inquiry must cover (for initial authorization, authorization update, and
 
authorization reinstatement)
Not included in clearance Burden accounted for under section 26.63(a), (c) and (e) 26.65(d) and (e): Record of reinstatement or administrative withdrawal of authorization          28.0                      4.0          112.0              26.0            4.0            104.0 (8.0)
Updated 26.65(f): Authorization reinstatement after an interruption --
record of administrative withdrawal of authorization under
 
section 26.65(d)(1)(ii) or (e)(2)(iii)(B)          28.0                      1.0            28.0              26.0            1.0              26.0 (2.0)
Duplicative Burden 26.67 Record of random D&A testing of persons who have applied for authorization and who have received a pre-acces s test, but who have yet to be granted authorization          28.0                      5.5          154.0 Burden accounted for under section 26.183(d)(2)(i)
(154.0)
Updated 26.69(b) and (c)(1): Authorization following a 1st or 2nd positive drug or alcohol test result, or if other PDI is identified
 
-- obtain, review, and retain an applicant's self-disclosure an d employment history Burden accounted for under section 26.713(a)(1)
Burden accounted for under section 26.61(a)
-
Updated 26.69(c)(2): Record that the licensee or other entity identified and resolved PDI (not reviewed and favorably resolved by a
 
previous licensee or other entity)          28.0                    40.0        1,120.0              26.0          62.5        1,624.4 504.4 Updated 26.69(c)(3): Record that the licensee or other entity verified that an applicant with a prior FFD testing violation (i.e., a 5-
 
year denial for a 2nd positive result) has abstained from
 
substance abuse for at least 5 years          28.0                    40.0        1,120.0 Burden accounted for under section 26.69(c)(4)
(1,120.0)        Updated 26.69(c)(4): Record that an SAE conducted a determination of fitness and concluded that an applicant with PDI is fit to
 
safely and competently perform duties (i.e., evaluated
 
clinically appropriate treatment and followup testing plans
 
were developed by an SAE -- for an applicant with a prior 1st
 
positive result; ensured treatment recommendations and
 
followup testing from an SAE's determination of fitness are
 
initiated -- for an applicant with a prior 2nd positive result; or
 
verified the applicant is in compliance with and successfully
 
completed any followup testing and treatment plans)          28.0                      3.0            84.0              26.0          40.0        1,040.0 956.0 Updated 26.69(c)(5): Record of negative results for pre-access D&A testing (needed prior to granting authorization)          28.0                      1.0            28.0              26.0          52.1        1,353.7 1,325.7        Updated 26.69(d): Record of reviewing official's determination on an applicant's request for access authorization          28.0                    24.0          672.0              26.0          24.0            624.0 (48.0)
Page 7 of 24 Final Supporting Statement, 10 CFR Part 26 Index Key:- New- Updated
- Moved
- Duplicative
- Removed Section Number of Record-keepers Burden Hours per Recordkeeper Total Annual Burden Hours Number of Record-keepers Burden Hours per Record-keeper Total Annual Burden Hours Table 2: Annual Recordkeeping Approved Clearance Values (approved 11/30/14 - ICR 201407-3150-Extension (2017-2020)
Burden Estimate Change Updated 26.69(e): Record that follow-up testing and treatment plan for an applicant from the D&A testing program of another
 
licensee or other entity has been verified (that is treatment
 
and follow-up testing successfully completed)          28.0                      8.0          224.0              26.0            8.0            208.0 (16.0)
Updated 26.69(e)(1): Record that information transmitted on testing and treatment plans to other FFD programs (at donor
 
request)          28.0                      8.0          224.0              26.0            8.0            208.0 (16.0)
Consolidated 26.75(a) - (e), and (g): Records of sanctions for FFD violations          28.0                    12.0          336.0 Burden accounted for under section 26.39(b)
(336.0)
Updated 26.75(h): Record that an individual's authorization was administratively withdrawn due to impairment confirmed
 
under section 26.189, or because the individual posed a
 
safety hazard          28.0                    18.0          504.0              26.0          15.6            405.3 (98.7)
Updated 26.75(i): Record of temporary administrative withdrawal of an individual's authorization due to an initial positive test result
 
for marijuana and/or cocaine at an LTF          28.0                    80.0        2,240.0  0        80.0                  -  (2,240.0)        Updated 26.75(i)(3): Eliminate from an individual's record any references to a temporary administrative withdrawal of
 
authorization due to an initial positive marijuana and/or
 
cocaine test result at an LTF that did not confirm positive
 
after testing at an HHS lab          28.0                      1.0            28.0  0          1.0                  -  (28.0)
Updated 26.85(a) and (b): Training of urine and alcohol collectors and maintain training records in personnel files          28.0                      8.0          224.0              26.0            8.0            208.0 (16.0)
Updated 26.87(d)(3): If a collection site cannot be dedicated solely to collecting specimens, secure the portion of the facility when a specimen collection is in process and post a sign indicating
 
access permitted only to authorized personnel          28.0                      1.0            28.0              26.0            1.0              26.0 (2.0)
Updated 26.87(f)(1) and (f)(3) - (f)(5): Post a sign outside the collection area (if a public restroom used) and document on
 
the custody-and-control form (CCF) the name of a same
 
gender observer (in the exceptional event that a designated
 
collection site is inaccessible, the collector is not the same
 
gender as the donor and a urine specimen must be
 
immediately collected)          28.0                      2.0            56.0                2.0            0.5                1.0 (55.0)
Updated 26.89(a): Collector notifies FFD management that a donor failed to report to the collection site          28.0                      1.0            28.0                4.0          0.25                1.0 (27.0) 26.89(b)(1), (b)(2), and (b)(4): Record that ID and consent-to-testing form obtained          28.0                      1.5            42.0              26.0            1.5              39.0 (3.0)
Updated 26.89(b)(3): Record that FFD management informed that an individual did not present identification (pre-access testing)          28.0                      1.0            28.0              26.0            1.0              26.0 (2.0)
Consolidated 26.89(c): Collector documents on CCF a donor's refusal to cooperate with the collection process          28.0                      1.0            28.0 Burden accounted for under section 26.107(b)
(28.0)
Updated 26.91(c)(1) - (c)(3): Record of evidential breath testing (EBT) device test results Burden accounted for under section 26.715(b)(2)
Burden accounted for under section 26.715(b)(2)
-
26.91(e)(4): Record that results cancelled after EBT calibration check failure              -                        6.0                -    0          6.0                  -  -                Updated 26.91(e)(5): EBT maintenance records          28.0                      6.0          168.0              26.0            6.0            156.0 (12.0)
Updated 26.93(a)(6): Document that alcohol pre-test questions communicated to the donor          28.0                    80.0        2,240.0              26.0          47.1        1,223.6 (1,016.4)      26.95(b)(5): Record donor identity for initial alcohol breath test          28.0                    80.0        2,240.0              26.0          47.1        1,223.6 (1,016.4)        Updated 26.97(b)(2): Record reason for new oral fluid alcohol test              -                        5.0                -    0        0.25                  -  -
Updated 26.97(c)(1): Document reason for failure of 2 nd collection attempt              -                        2.5                -    0        0.25                  -  -              26.97(d): Record results and alcohol screening device used              -                      0.25                -    0        0.25                  -  -
Updated 26.99(b): Record time of initial alcohol test of 0.02 percent or higher blood alcohol concentration (BAC)
Burden accounted for under section 26.715(b)(2)
Burden accounted for under section 26.715(b)(2)
-
Duplicative Burden 26.101(b)(7): Record time and BAC result of confirmatory alcohol test              -                        -                  -
Burden accounted for under section 26.715(b)(2)
-
Updated 26.103(b): Record that FFD management notified of a confirmatory alcohol test result of 0.01 to 0.02 percent BAC            8.0                    0.25              2.0                8.0          0.25                2.0 -
Updated 26.107(b): Collector documents on CCF any donor conduct during collection process indicating an attempt to tamper with
 
a specimen, and notifies FFD management          28.0                      0.1              2.8              26.0          0.25                6.5 3.7 Updated 26.109(b)(3): Collector documents on CCF that the donor was unable to provide a specimen in the 3-hour time allotted (i.e., a shy bladder), and notifies FFD management          28.0                      0.5            14.0              26.0          0.25                6.5 (7.5)
Page 8 of 24 Final Supporting Statement, 10 CFR Part 26 Index Key:- New- Updated
- Moved
- Duplicative
- Removed Section Number of Record-keepers Burden Hours per Recordkeeper Total Annual Burden Hours Number of Record-keepers Burden Hours per Record-keeper Total Annual Burden Hours Table 2: Annual Recordkeeping Approved Clearance Values (approved 11/30/14 - ICR 201407-3150-Extension (2017-2020)
Burden Estimate Change Consolidated 26.109(b)(4): Collector documents on CCF if a specimen (less than 30 mL) appears to be tampered with and/or donor
 
behavior during collection indicated a possible subversion
 
attempt, and notifies FFD management          28.0                      0.3              8.4 Burden accounted for under section 26.107(b)
(8.4)
Consolidated 26.111(b): Collector documents on CCF if specimen characteristics (color, clarity) indicate possible tampering by
 
the donor            4.0                      0.3              1.0 Burden accounted for under section 26.107(b)
(1.0)
Consolidated 26.111(c): Collector documents on CCF unusual specimen temperature and/or observations during the collection
 
indicating possible tampering, and notifies FFD management.          28.0                      0.3              8.4 Burden accounted for under section 26.107(b)
(8.4)
Updated 26.113(b)(3): Collector completes CCF for split-specimen collection          28.0                      0.3              8.4 Burden accounted for under section 26.117(c) - (e)
(8.4)
Updated 26.115(b): Collector documents on CCF approval from FFD manager or MRO to collect a specimen under direct
 
observation          28.0                      0.5            14.0              26.0            0.5              13.0 (1.0)
Duplicative Burden 26.115(d): Collector documents on CCF that observed collection performed and reason for the observed collection          28.0                      0.3              8.4 Burden accounted for under section 26.115(b)
(8.4)
Duplicative Burden 26.115(f)(3): Collector documents on CCF the name of observer of directly observed collection          28.0                      0.3              8.4 Burden accounted for under section 26.115(b)
(8.4)
Updated 26.117(c) - (e): Collector prepares ID labels and CCF forms for specimen shipment          28.0                    60.0        1,680.0              26.0        188.2        4,894.4 3,214.4        Updated 26.119(a), (e), and (f):  Written evaluation from the physician who performed a medical evaluation of a donor with a shy
 
bladder (i.e., unable to provide a specimen of adequate
 
volume in the allotted 3-hours)          28.0                      6.0          168.0              13.0            2.0              26.0 (142.0)
Updated 26.119(b): Record that MRO provided information and instructions to the physician who is to perform the
 
examination of a donor with a shy bladder          28.0                      2.0            56.0              13.0            1.0              13.0 (43.0)
Updated 26.125(b) and (c): Records on the proficiency and qualifications of LTF personnel            7.0                    16.0          112.0                6.0          16.0              96.0 (16.0)
Updated 26.127 (a) - (e): Maintain LTF written procedures on the handling of specimens, chain-of-custody procedures, testing
 
assays, instrument and device setup, and remedial actions
 
for systems and testing devices.            7.0                  200.0        1,400.0                6.0          40.0            240.0 (1,160.0)        Updated 26.129(a): Maintain documentation of access to secure area s of an LTF by all authorized individuals (i.e., an access log)            7.0                      2.5            17.5                6.0            4.0              24.0 6.5 Updated 26.129(b): LTF inspects specimen packages, CCFs, and obtains memorandum from specimen collectors to correct
 
identified discrepancies            7.0                      0.5              3.5                6.0            0.5                3.0 (0.5)
Updated 26.129(b)(1): LTF record of report to senior licensee or other entity management of attempts to tamper with specimens in
 
transit            7.0                      1.0              7.0  0          1.0                  -  (7.0)              26.129(d): LTF procedures for tracking CCF of specimens            7.0                    80.0          560.0                6.0          80.0            480.0 (80.0)
Updated 26.135(b): LTF record of direction from MRO to send Bottle B of a split specimen to a second HHS lab for testing            7.0                      2.2            15.4                6.0            0.5                3.0 (12.4) 26.137(a): Record of a QA/QC program and procedures for LTF            7.0                      4.0            28.0                6.0            4.0              24.0 (4.0)
Updated 26.137(b)(1)(ii): LTF documentation of performance testing of a device not approved by SAMHSA for point-of-collection
 
testing            2.0                    40.0            80.0  0        40.0                  -  (80.0)
Updated 26.137(b)(1)(iii): LTF documentation of annual test results for a device not approved by SAMHSA for point-of-collection
 
testing            2.0                    20.0            40.0  0        20.0                  -  (40.0)
Updated 26.137(b)(3): LTF records submitting 1 in 10 specimens that test negative on validity screening testing are sent to an HHS
 
lab as part of the LTF's QA program            7.0                    40.0          280.0  0        40.0                  -  (280.0)
NEW 26.137(d)(6): LTF records that 1 in 10 specimens that test negative on initial validity testing are sent to an HHS lab for
 
testing as part of the LTF's QA program Not included in clearance                6.0          40.0            240.0 240.0 Duplicative Burden 26.137(e)(7): LTF documented procedures to protect against carryover material            7.0                      2.0            14.0 Burden accounted for under section 26.127 (a) - (e)
(14.0)            Updated 26.137(f)(5): LTF records on testing errors            7.0                    24.0          168.0                6.0            8.0              48.0 (120.0)          Updated 26.137(h): LTF labeling of standards and controls            7.0                    65.0          455.0                6.0          40.0            240.0 (215.0)
Updated 26.139(d): Record that the LTF prepared a summary of test results for inclusion in the FFD annual program performance
 
report submitted under section 26.717            7.0                    40.0          280.0                6.0          40.0            240.0 (40.0)
Moved (to Table 1) 26.153(e): Record of pre-award inspection of new HHS lab (completed prior to awarding contract for testing services)          28.0                    40.0        1,120.0  Moved to Table 1 (1,120.0)        Moved (to Table 1) 26.153(f): Records that Part 26 specified requirements included in contract with HHS lab          28.0                    40.0        1,120.0  Moved to Table 1 (1,120.0)      Page 9 of 24 Final Supporting Statement, 10 CFR Part 26 Index Key:- New- Updated
- Moved
- Duplicative
- Removed Section Number of Record-keepers Burden Hours per Recordkeeper Total Annual Burden Hours Number of Record-keepers Burden Hours per Record-keeper Total Annual Burden Hours Table 2: Annual Recordkeeping Approved Clearance Values (approved 11/30/14 - ICR 201407-3150-Extension (2017-2020)
Burden Estimate Change Updated 26.153(g): Record of memorandum sent to the HHS lab explaining use of non-federal CCF form          28.0                      0.5            14.0              26.0            0.5              13.0 (1.0)
Updated 26.159(b)(1): Record that the licensee or other entity received noticed from an HHS lab within 24 hours of the lab
 
identifying evidence of tampering with specimen.          28.0                      1.0            28.0  0          1.0                  -  (28.0) 26.159(i): Record of written authorization to store specimens other than 1 year          28.0                      0.5            14.0              26.0            0.5              13.0 (1.0)
Duplicative Burden 26.163(a)(2): Record that special analyses testing conducted on a dilute specimen and report of the test results          28.0                      1.0            28.0 Burden accounted for under section 26.169(c)(1)
(28.0)
Duplicative Burden 26.165(b)(1): Record of a donor request for the retesting of an aliquot of a single specimen or the testing of the Bottle B
 
split specimen at a second HHS lab          28.0                      1.0            28.0 Burden accounted for under section 26.165(b)(6)
(28.0)
Duplicative Burden 26.165(b)(2): Record that MRO informed the donor of the opportunity to request the retesting of an aliquot of a single
 
specimen or the testing of the Bottle B split specimen at a
 
second HHS lab          28.0                      0.5            14.0 Burden accounted for under section 26.185(c)
(14.0)
Updated 26.165(b)(3): Donor's written permission provided to the MRO for the retesting of an aliquot of a single specimen or
 
the testing of the Bottle B split specimen at a second HHS
 
lab Burden accounted for under section 26.165(b)(1)
Burden accounted for under section 26.165(b)(6)
-
Duplicative Burden 26.165(b)(4): Record that the donor presented documentation to the MRO on the inability to submit a timely
 
request to initiate specimen retesting at a second HHS lab            6.0                      0.2              1.2 Burden accounted for under section 26.185(c)
(1.2)
Updated 26.165(b)(6): MRO reviews HHS lab results on the retesting of an aliquot of a single specimen or testing of the Bottle B
 
split specimen, informs the donor of the results, and notified
 
FFD management          28.0                      3.0            84.0              26.0            1.2              31.1 (53.0)
Updated 26.165(c)(4): Results report received from the second HHS lab that performed retesting an aliquot of a single specimen
 
or the testing of the Bottle B split specimen          12.0                      2.5            30.0 Burden accounted for under section 26.165(b)(6)
(30.0)
Updated 26.165(f)(1): Adjustments to personnel files and written notifications regarding the results of retesting an aliquot of a
 
single specimen or testing of the Bottle B split specimen, including temporary administrative action          28.0                      6.0          168.0  0          6.0                  -  (168.0)
Updated 26.165(f)(1)(iv) and (f)(2): Written record and notice that records purged of references to temporary administrative
 
action          28.0                      8.0          224.0  0          8.0                  -  (224.0)
Updated 26.167(f)(3): Record received from the Responsible Person of an HHS lab on a false positive BPTS testing error (determined to be technical or methodological),
demonstrating that retesting of all positive, adulterated, substituted, and invalid specimens from the time of final
 
resolution of the error back to the time of the last satisfactory
 
performance test cycle has been completed          12.0                      1.0            12.0  0          1.0                  -  (12.0)
NEW 26.168(a) Maintain documentation of HHS lab certification of BPTS formulation Not included in clearance              26.0            2.6              67.0 67.0 Moved (from Table 4) 26.168(i)(2): Licensee or other entity completes CCF for a BPTS, places fictional initials on specimen labels, and
 
indicates on the MRO copy of the CCF that the specimen is a BPTS  Moved from Table 4              26.0          34.4            893.3 893.3 Updated 26.169(a): Records of reports of test results from the HHS lab Burden covered under section 26.169(c)(1) through (c)(5)
Burden accounted for under section 26.183(c)(1)
-
Duplicative Burden 26.169(c)(1): Records of HHS lab reports of positive, adulterated, substituted, dilute, and invalid test results
 
received by the MRO          12.0                    80.0          960.0 Burden accounted for under section 26.183(c)(1)
(960.0)
Duplicative Burden 26.169(c)(2): Records of HHS lab reports of the numerical values of all positive drug test results (i.e., quantitative test
 
results requested by MRO)          12.0                      1.0            12.0 Burden accounted for under section 26.183(c)(1)
(12.0)
Duplicative Burden 26.169(c)(2): Records of HHS lab reports of quantitative test results for opiates          12.0                      0.5              6.0 Burden accounted for under section 26.183(c)(1)
(6.0)
Duplicative Burden 26.169(c)(3): Records of HHS lab reports of quantitative test results for adulterated or substituted test results          12.0                      2.5            30.0 Burden accounted for under section 26.183(c)(1)
(30.0)
Duplicative Burden 26.169(c)(4): Record of MRO contact with HHS lab to discuss whether testing by another HHS lab should be
 
conducted on a specimen with an invalid result          12.0                      2.0            24.0 Burden accounted for under section 26.185(f)(1)
(24.0)
Duplicative Burden                2.0                      1.0              2.0 Burden accounted for under section 26.183(c)(1)
(2.0)
Updated 26.169(f): Records of HHS lab transmittals of CCF copies for negative results to the MRO          12.0                  109.5        1,314.0              26.0          47.1        1,223.6 (90.4)
Page 10 of 24 Final Supporting Statement, 10 CFR Part 26 Index Key:- New- Updated
- Moved
- Duplicative
- Removed Section Number of Record-keepers Burden Hours per Recordkeeper Total Annual Burden Hours Number of Record-keepers Burden Hours per Record-keeper Total Annual Burden Hours Table 2: Annual Recordkeeping Approved Clearance Values (approved 11/30/14 - ICR 201407-3150-Extension (2017-2020)
Burden Estimate Change Duplicative Burden 26.169(g): HHS lab copy of the original CCF for each positive, adulterated, substituted, dilute, and invalid test
 
results to the MRO          12.0                    44.7          536.4 Burden accounted for under section 26.169(c)(1)
(536.4)
Updated 26.169(h): Record of HHS lab statistical summary report of urinalysis testing results (for the calendar year)          12.0                    40.0          480.0              26.0            2.0              52.0 (428.0)          Updated 26.183(a): Documentation of MRO qualifications          28.0                      3.5            98.0              26.0            4.0            104.0 6.0 Updated 26.183(c)(1): MRO review of HHS lab test result record for positive, adulterated, substituted, invalid, or at the licensee's
 
or other entity's discretion, dilute specimen          28.0                    19.1          534.8              26.0            2.0              51.8 (483.1)
Updated 26.183(d)(1)(ii)(D): Record of MRO report of confirmed drug positive, adulterated, substituted, or refusal to test result to
 
the licensee's designated reviewing official          28.0                    19.1          534.8              26.0            2.0              51.8 (483.1)
Updated 26.183(d)(2)(i): Record of MRO staff review and reporting of negative test results to FFD management          28.0                  292.2        8,181.6              26.0        282.4        7,341.5 (840.1)
Updated 26.183(d)(2)(ii): Record of MRO staff review of CCFs for positive, adulterated, substituted and invalid results and
 
forwards changes to MRO for review          28.0                      1.9            53.2              26.0            2.4              62.1 8.9 Updated 26.185(a) Record of MRO review of a drug positive, adulterated, substituted, dilute, or invalid HHS lab test result          28.0                    26.0          728.0 Burden accounted for under section 26.183(c)(1)
(728.0)
Updated 26.185(c): Record of MRO discussion of positive, adulterated, substituted, dilute, or invalid test result with
 
donor          28.0                    26.0          728.0              26.0          11.9            310.5 (417.5)
Duplicative Burden 26.185(d)(1): Documentation that donor declined to discuss test results with MRO          28.0                      2.0            56.0 Burden accounted for under section 26.185(c)
(56.0)
Updated 26.185(e): Documentation reviewed by the MRO on a donor' s inability to discuss test results and a request to reopen proceeding          28.0                      0.3              8.4              26.0            0.5              13.0 4.6 Updated 26.185(f)(1): Record of MRO consultation with HHS lab to determine whether additional testing needed for an invalid
 
specimen          28.0                      0.5            14.0              26.0            0.5              13.0 (1.0)
Duplicative Burden 26.185(f)(2): Record of MRO contact with donor about an invalid test result, and medical information received          28.0                      0.5            14.0 Burden accounted for under section 26.185(c)
(14.0)
Duplicative Burden 26.185(h)(1): Record of MRO contact with donor about a substituted test result, and medical information received          28.0                      2.0            56.0 Burden accounted for under section 26.185(c)
(56.0)
Duplicative Burden 26.185(h)(2): Record of MRO confirmation of a substituted test result (no legitimate medical explanation)          28.0                      2.0            56.0 Burden accounted for under section 26.183(d)(1)(ii)(D)
(56.0)
Duplicative Burden 26.185(h)(3): MRO record of determination of a legitimate medical explanation for a substituted test result          28.0                      1.0            28.0 Burden accounted for under section 26.183(d)(2)(i)
(28.0)
Duplicative Burden 26.185(i)(1): Record of MRO contact with donor about an adulterated test result, and medical information received          28.0                      2.0            56.0 Burden accounted for under section 26.185(c)
(56.0)
Duplicative Burden 26.185(i)(2): Record of MRO confirmation of an adulterated test result (no legitimate medical explanation)          28.0                      2.0            56.0 Burden accounted for under section 26.183(d)(1)(ii)(D)
(56.0)
Duplicative Burden 26.185(i)(3): MRO record of determination of a legitimate medical explanation for an adulterated test result          28.0                      1.0            28.0 Burden accounted for under section 26.183(d)(2)(i)
(28.0)
Updated 26.185(j): Prescription medication drug positives (applies to amphetamine, morphine, and codeine results) - records of
 
MRO review of HHS lab result, discussion of positive result
 
with donor, and review medication information from the donor          28.0                      1.5            42.0              26.0            2.3              60.0 18.0 Duplicative Burden 26.185(k): Record of MRO report to licensee that no FFD policy violation has occurred (i.e., legitimate prescription
 
medication used in a manner and at the dosage prescribed). 
 
If the individual poses a potential risk to public health and
 
safety because of impairment while on duty - the MRO will
 
ensure that a determination of fitness is performed)          28.0                      1.0            28.0 Burden accounted for under sections 26.183(d)(2)(i) and 26.185(c)(28.0) 26.185(m): Record of MRO review of inspection and audit reports, QC data, multiple specimens, and other data to
 
determine if positive, adulterated, substituted, or invalid resul t is scientifically insufficient for determination of FFD policy
 
violation          28.0                      1.0            28.0              26.0            1.0              26.0 (2.0)
Updated 26.185(n): Record of MRO review of a positive, adulterated or substituted test result from a second HHS lab (results of
 
retesting a single specimen or testing of a Bottle B split
 
specimen), and MRO communication of the test result to the
 
donor, and report results to FFD management          28.0                      2.0            56.0              26.0          0.60              15.5 (40.5)
Updated 26.185(o): Record of MRO request and HHS lab report of quantitation test results for testing performed on a specimen
 
from a donor applying for reauthorization following a 1st
 
positive drug test result          28.0                      1.5            42.0              26.0          0.50              13.0 (29.0)
Duplicative Burden 26.185(p): MRO written notice to licensee or other entity of a positive, adulterated, substituted, or invalid test result          28.0                      8.0          224.0 Burden accounted for under section 26.185(c)
(224.0)
Page 11 of 24 Final Supporting Statement, 10 CFR Part 26 Index Key:- New- Updated
- Moved
- Duplicative
- Removed Section Number of Record-keepers Burden Hours per Recordkeeper Total Annual Burden Hours Number of Record-keepers Burden Hours per Record-keeper Total Annual Burden Hours Table 2: Annual Recordkeeping Approved Clearance Values (approved 11/30/14 - ICR 201407-3150-Extension (2017-2020)
Burden Estimate Change Consolidated 26.713(a)(2): Records pertaining to the determination of a violation of FFD policy and related management actions          28.0                    80.0        2,240.0 Burden accounted for under section 26.39(b)
(2,240.0)        Updated 26.713(a)(3): Documentation of the granting and termination of authorization          28.0                    80.0        2,240.0              26.0          80.0        2,080.0 (160.0)
Updated 26.713(a)(4):  Records of determinations of fitness performed under section 26.189 (including recommendations
 
for treatment and followup testing plans)          28.0                    80.0        2,240.0              26.0          80.0        2,080.0 (160.0)
Duplicative Burden 26.713(b)(1): Records of FFD training and examinations conducted under section 26.29          28.0                  160.0        4,480.0 Burden accounted for under sections 26.29(a) and (b)
(4,480.0)        Duplicative Burden 26.713(b)(2): Records of audits, audit findings, and correctiv e actions taken under section 26.41          28.0                    80.0        2,240.0 Burden accounted for under sections 26.41(a)-(d), (f) and (g)
(2,240.0)        Consolidated 26.713(c):  Records on 5-year and permanent denials of authorization          28.0                    40.0        1,120.0 Burden accounted for under section 26.39(b)
(1,120.0)        Updated 26.713(d): Records of superseded versions of FFD policies and procedures          28.0                    80.0        2,240.0              26.0            8.0            208.0 (2,032.0)        Updated 26.713(e): Records of written agreements for services under Part 26          28.0                    16.0          448.0              26.0          16.0            416.0 (32.0)
Duplicative Burden 26.713(f): Records of background investigations, credit and criminal history checks, and psychological assessments of
 
FFD program personnel conducted under section
 
26.31(b)(1)(i)          28.0                    80.0        2,240.0 Burden accounted for under section 26.31(b)(1)(i)
(2,240.0)        Moved (to Table 1) 26.713(g): Documentation on testing for additional drugs as permitted under section 26.31(d)(1), use of more stringent
 
testing cutoff levels as permitted under section 26.31(d)(3),
or both          28.0                    40.0        1,120.0  Moved to Table 1 (1,120.0)        Updated 26.715(a): Documentation of all aspect of testing process at collection sites and LTFs (not otherwise specified in section
 
26.715(b))          28.0                    40.0        1,120.0              26.0          40.0        1,040.0 (80.0)
Updated 26.715(b)(1): Retain personnel files on staff at collection site s and LTFs          28.0                    20.0          560.0              26.0          20.0            520.0 (40.0)
Updated 26.715(b)(2): Retain collection site and LTF chain-of-custody documents          28.0                  240.0        6,720.0              26.0        240.0        6,240.0 (480.0)          Updated 26.715(b)(3): Retain LTF QA/QA records          28.0                  120.0        3,360.0                6.0        120.0            720.0 (2,640.0)        Updated 26.715(b)(4): Retain superseded procedures (LTFs and collection sites)          28.0                    40.0        1,120.0              26.0          40.0        1,040.0 (80.0)
Updated 26.715(b)(5): Retain all test data from LTF (including calibration curves and any calculations used in determining
 
test results          28.0                  240.0        6,720.0                6.0        240.0        1,440.0 (5,280.0)        Updated 26.715(b)(6):  LTF test reports          28.0                  240.0        6,720.0                6.0        240.0        1,440.0 (5,280.0)        Updated 26.715(b)(7):  LTF performance testing records          28.0                    80.0        2,240.0                6.0          80.0            480.0 (1,760.0)        Updated 26.715(b)(8): Records from LTF and HHS lab on the investigation of testing errors or unsatisfactory performance, and any corrective actions taken          28.0                    40.0        1,120.0                8.0          40.0            320.0 (800.0)
Moved (to Table 4) 26.715(b)(9): Performance records on HHS lab certification inspections          28.0                    40.0        1,120.0  Moved to Table 4 (1,120.0)        Updated 26.715(b)(10): Records of preventative maintenance on LTF instruments          28.0                    40.0        1,120.0                6.0          40.0            240.0 (880.0)
Updated 26.715(b)(11): Retain records that summarize any test results the MRO determined to be scientifically insufficient for
 
further action          28.0                    20.0          560.0                1.0            3.0                3.0 (557.0)          Updated 26.715(b)(12): LTF retains computer-generated data          28.0                  120.0        3,360.0                6.0        120.0            720.0 (2,640.0)        Duplicative Burden 26.715(b)(13): Retain records (e.g., an access log) of authorized visitors, maintenance personnel and service
 
personnel who accessed LTF secure areas          28.0                    20.0          560.0 Burden accounted for under section 26.129(a)
(560.0)
Updated 26.715(b)(14): Retain records of the inspection, maintenance and calibration of EBTs (collection sites)          28.0                    20.0          560.0              26.0          20.0            520.0 (40.0) 26.717(a) and (b): Collect FFD performance data for D&A testing programs          28.0                  100.0        2,800.0              26.0        100.0        2,600.0 (200.0) 26.717(a) and (b): Collect FFD performance data for fatigue management program          23.0                  100.0        2,300.0              21.0        100.0        2,100.0 (200.0)          26.717(c): Analyze D&A testing program FFD data annually          28.0                    40.0        1,120.0              26.0          40.0        1,040.0 (80.0) 26.717(c): Analyze fatigue management program data annually          23.0                    40.0          920.0              21.0          40.0            840.0 (80.0)            26.717(d): D&A test results leading to termination            1.0                      1.0              1.0                1.0            1.0                1.0 -
Duplicative Burden 26.717(g): Collect and report D&A testing program data to the NRC (for C/V with a testing program)            1.0                  120.0          120.0 Burden accounted for under section 26.717(a) and (b)
(120.0)
Updated 26.719(b): Prepare information to make a 24-hour event report to the NRC            1.2                      1.0              1.2              37.0            1.0              37.0 35.8              Updated 26.719 (c): Prepare 30-day event report documentation.            0.2                    40.0              8.0                8.0          40.0            320.0 312.0 26.719(d): Document non-reportable indicators of FFD program weaknesses          30.0                    20.0          600.0              28.0          20.0            560.0 (40.0)
Page 13 of 24 Final Supporting Statement, 10 CFR Part 26 Index Key:- New- Updated
- Moved
- Duplicative
- Removed Section Number of Record-keepers Burden Hours per Recordkeeper Total Annual Burden Hours Number of Record-keepers Burden Hours per Record-keeper Total Annual Burden Hours Table 2: Annual Recordkeeping Approved Clearance Values (approved 11/30/14 - ICR 201407-3150-Extension (2017-2020)
Burden Estimate Change26.187(d): SAE training requirements          28.0                    20.0          560.0              26.0          20.0            520.0 (40.0)            26.187(f): Documentation of  SAE credentials and training          28.0                      1.0            28.0              26.0            1.0              26.0 (2.0)              Updated 26.189(b): Determination of fitness record          28.0                    80.2        2,245.6              26.0          80.0        2,080.0 (165.6)          Updated 26.189(c): Record of for cause determination of fitness          28.0                    16.3          456.4              26.0          15.6            405.3 (51.1)
Updated 26.189(d): Record of modification of an initial determination of fitness          28.0                      1.0            28.0                1.0            1.0                1.0 (27.0) 26.203(a): Prepare fatigue management policy (In addition to 26.27 burden)            2.0                      7.3            14.6  0          7.3                  -  (14.6) 26.203(b): Prepare fatigue management procedures (in addition to 26.27 burden)            2.0                      1.7              3.4  0          1.7                  -  (3.4)              26.203(c): Prepare training on fatigue management.            2.0                      2.0              4.0  0          2.0                  -  (4.0)
Updated 26.203(d)(1) and (d)(2): Records of work hours, shift schedules, and shift cycles Burden accounted for under 26.205(c), (d)(1), and (e)(4)
Burden accounted for under 26.205(c), (d)(1), and (e)(4)
-
26.203(d)(3): Documentation of waivers Burden accounted for under section 26.207(a)(4)
Burden accounted for under section 26.207(a)(4)
-
26.203(d)(4): Documentation of work hour reviews Burden accounted for under 26.205(d)(2), (e)(3) and (e)(4)
Burden accounted for under 26.205(d)(2), (e)(3) and (e)(4)
-
26.203(d)(5): Documentation of fatigue assessment Burden accounted for under section 26.211(f)
Burden accounted for under section 26.211(f)
-              26.205(b): Record of calculation of work hours          23.0                  160.0        3,680.0              21.0        160.0        3,360.0 (320.0)          26.205(c): Schedule work hours          23.0              2,080.0      47,840.0              21.0    2,080.0      43,680.0 (4,160.0)      26.205(d)(1): Record of implementation of  work hour controls          23.0                    50.0        1,150.0              21.0          50.0        1,050.0 (100.0)          26.205(d)(2): Record of adequate rest breaks          23.0                    50.0        1,150.0              21.0          50.0        1,050.0 (100.0) 26.205(e)(1) and (2): Record of review of control of work hours twice per calendar year          23.0                    40.0          920.0              21.0          40.0            840.0 (80.0)            26.205(e)(3): Document methods for reviews          23.0                    20.0          460.0              21.0          20.0            420.0 (40.0) 26.205(e)(4): Record and trend problems in regarding work hours          23.0                    20.0          460.0              21.0          20.0            420.0 (40.0)            Updated 26.207(a)(4): Document basis for waiver            3.0                      6.0            18.0              21.0            6.0            126.0 108.0          26.211(f): Document results of fatigue assessments          23.0                    50.0        1,150.0              21.0          50.0        1,050.0 (100.0)
NEW 26.403(a):  Updates to FFD policy and procedures (reactor construction site D&A testing program) Not included in clearance                2.0          16.0              32.0 32.0 Moved (from Table 1) 26.403(a): Provide FFD policy to individuals subject to a reactor construction site D&A testing program  Moved from Table 1                2.0            8.0              16.0 16.0              Updated 26.405(b): Records of random D&A tests            2.0                  705.0        1,410.0                2.0        193.9            387.7 (1,022.3)        Updated 26.405(c)(1): Records of pre-assignment D&A test            2.0              2,338.0        4,676.0                2.0        287.4            574.8 (4,101.2)        Updated 26.405(c)(2) and (c)(3): Records of for-cause and post accident D&A tests            2.0                  197.0          394.0                2.0        308.8            617.7 223.7            Updated 26.405(c)(4): Records of follow-up D&A tests            2.0                    34.5            69.0                2.0          21.1              42.1 (26.9)
Moved (to Table 1) 26.405(d): Record of testing for specified drugs, adulterants, and alcohol, at Part 26 specified cutoff levels Burden accounted for under section 26.405(a) - (c)(4)  Moved to Table 1 -
Updated 26.405(e): Updates to specimen collection and D&A testing procedures to protect the donor's privacy, integrity of the
 
specimen, and stringent quality controls to ensure accurate
 
test results            2.0                    40.0            80.0                2.0          40.0              80.0 -              26.405(f): Record that testing conducted at an HHS lab            2.0                    40.0            80.0                2.0          40.0              80.0 -
Updated 26.405(g): Record of MRO review of positive, adulterated, substituted, and invalid drug and validity test results (reactor
 
construction site D&A testing program)            2.0                    50.0          100.0                2.0          81.3            162.5 62.5 Updated 26.406(c): Updates to fitness monitoring procedures (programs that do not adopt random testing and behavioral
 
observation)              -                      80.0                -    0        80.0                  -  -
Updated 26.411(a): Updates to procedures for maintaining a system of files to protect personal information collected under
 
Subpart K of Part 26            2.0                      4.0              8.0                2.0          40.0              80.0 72.0 Updated 26.411(a) and (b): Collection of personal information under Subpart K of Part 26            2.0              2,190.5        4,381.0                2.0    3,817.0        7,634.0 3,253.0        26.413: Document results of review process            2.0                    80.0          160.0                2.0          80.0            160.0 -              26.415: Document and report audit results            2.0                    40.0            80.0                2.0          40.0              80.0 -
Updated 26.417(a): Records pertaining to the administration of a reactor construction site D&A testing program            2.0                    20.0            40.0                2.0          20.0              40.0 -
NEW 26.417(b)(1): Report to NRC by telephone within 24 hours programmatic failures in a reactor construction site D&A
 
testing program Not included in clearance Burden accounted for under section 26.719(b)
Updated 26.417(b)(2) Collect FFD program performance data for reactor construction site D&A testing program            2.0                  100.0          200.0                2.0        100.0            200.0 -
Duplicative Burden 26.713(a)(1): Records of self-disclosures, employment histories, and suitable inquiries (under sections 26.55, 26.57, 26.59, and 26.69) that result in the granting of authorization          28.0                    80.0        2,240.0 Burden accounted for under section 26.61(a), and 26.63(a), (c), and (e)
(2,240.0)      Page 12 of 24 Final Supporting Statement, 10 CFR Part 26 Index Key:- New- Updated
- Moved
- Duplicative
- Removed Section Number of Record-keepers Burden Hours per Recordkeeper Total Annual Burden Hours Number of Record-keepers Burden Hours per Record-keeper Total Annual Burden Hours Table 2: Annual Recordkeeping Approved Clearance Values (approved 11/30/14 - ICR 201407-3150-Extension (2017-2020)
Burden Estimate Change Updated 26.821(a): Provide NRC with access to records (to inspect, copy, or take away copies of records)          30.0                      4.0          120.0              28.0            4.0            112.0 (8.0)
Updated 26.821(b): Written agreement between C/Vs and licensees to permit authorized NRC representatives to inspect, copy, or
 
take away copies of C/Vs documents, records, and reports            1.0                      4.0              4.0                1.0            4.0                4.0 -              Table 2 Total  314,177.4      220,886.5 (93,290.9)    -29.7%Page 14 of 24 FINAL Supporting Statement, 10 CFR Part 26 Index Key:- Updated- Removed Section Number of Respondents Responses per Respondent Total Responses Burden per Response (hours)Total Burden Hours Number of Respondents Responses per Respondent Total Responses Burden per Response (hours)Total Burden Hours26.9: Application to NRC for exemption 0                    1.0                  -                      -                  -  0                  1.0                  -                    -                  -                    -  Updated26.77(c) Report impaired NRC employee                    30.0                        -                    -                    1.0                -  0                    -                    -                  1.0                -         
          -
Updated 26.137(b)(3): Report false negative LTF validity screening result Burden accounted for under section 26.719(c)(3)
No LTF conducts validity screening testing (if any did, burden would be accounted for under section 26.719(c)(3)
                -
Removed 26.139(d): Prepare information from LTF for annual FFD program performance report Burden accounted for under section 26.717(e) and (f)
REMOVED (Activity covered in Table 2)
                -
Removed 26.187(f): Provide SAE qualifications documentation to NRC upon request                      1.0                      1.0                1.0                  1.0              1.0 REMOVED (Activity covered in Table 2)
(1.0)
Updated 26.203(e)(1): Prepare information on waivers of work hour controls for inclusion
 
in FFD program performance report to NRC
 
required by 26.717                    23.0                      1.0              23.0                50.0      1,150.0                    21.0                  1.0              21.0              50.0        1,050.0          (100.0)
Updated 26.203(e)(2): Prepare summary of fatigue corrective actions for inclusion in FFD
 
program performance report to NRC
 
required by 26.717                    23.0                      1.0              23.0 6.0          138.0                    21.0                  1.0              21.0                6.0          126.0            (12.0) Updated 26.417(b)(1): Report to NRC by telephone within 24 hours of identifying a
 
programmatic failure in a reactor
 
construction site D&A testing program                      2.0                      1.0                2.0                  4.0              8.0  Burden accounted for under section 26.719(b)              (8.0)
Updated 26.417(b)(2): Prepare annual FFD program performance report for reactor construction
 
site D&A testing program                      2.0                      1.0                2.0                80.0          160.0                      2.0                  1.0                2.0              80.0          160.0                -
Removed 26.717(d): Report termination drug and alcohol test results in annual program
 
performance summary by processing stage Burden accounted for under section 26.717(e) and (f). NRC's 2012 FFD program performance indicate 1,089 positive, adulterated, substituted, and refusal to test results. Removed (All burden is captured under a single 26.717 line items for D&A results)
                -
Updated 26.717: Annual FFD program performance report for fatigue management programs                    62.0                      1.0              62.0                  8.0          496.0                    59.0                  1.0              59.0                8.0          472.0            (24.0)
Updated 26.717: Annual FFD program performance for D&A testing programs                    65.0                      1.0              65.0                60.0      3,900.0                    67.0                  1.0              67.0              60.0        4,020.0            120.0 Updated 26.719(a): Report a significant FFD program violation, programmatic failure,  or
 
D&A testing error Burden accounted for under section 26.719(b) and (c)  Burden reported under sections 26.719(b), and (c)(1) - (c)(3)         
      -
Updated 26.719(b): Report to the NRC by telephone within 24 hours of identifying a significant
 
D&A testing violation                    15.0                      2.5              37.1                  4.0          148.2                    37.0                  1.0              37.0                4.0          148.0              (0.2)
Updated 26.719(c)(1): Submit a report to the NRC within 30 days of completing an
 
investigation into an LTF or HHS lab testing
 
error                      6.0                      1.0                6.0                24.0          144.0                      8.0                  1.0                8.0              24.0          192.0              48.0 Updated 26.719(c)(2): Notify the NRC by telephone within 24 hours of receiving notice of a false
 
positive on a BPTS test result                      1.0                      1.0                1.0                  4.0              4.0 0                  1.0                  -                  4.0                -                (4.0)
Updated 26.719(c)(3): Notify the NRC by telephone within 24 hours of receiving a false negative
 
test result on a QA check of a validity
 
screening test from an LTF                      4.0                      1.0                4.0                  4.0            16.0 0                  1.0                  -                  4.0                -              (16.0)Table 3 Total            226.1      6,165.2            215.0        6,168.0                2.8 Approved Clearance Values (approved 11/30/14 - ICR 201407-3150-007)
Extension (2017-2020)
Table 3: Annual Reporting Burden Estimate Change Page 15 of 24 FINAL Supporting Statement, 10 CFR Part 26 Index Key:- Consolidated- Duplicative
- Moved
- New
- Removed
- Updated Section Number of Responses Burden Hours per Response Total Annual Burden Hours Number of Responses Burden Hours per Response Total Annual Burden Hours Updated 26.4(j):  For personnel granted authorization by a licensee, who are covered by a D&A testing program regulated by a
 
State or Federal agency - (1) provision of training record to
 
the licensee to demonstrate section 26.29(a) training
 
requirements met (if not already covered in the existing
 
program); (2) notification of any FFD policy violations by
 
those granted authorization by the licensee or other entity                14.0                  2.0                28.0                33.5                  2.0              67.0 39
.0 Moved (from Table 1) 26.29(b): Complete initial training on FFD policy and take comprehensive examination Not included in clearance (was in Table 1 but zero programs)          81,219.3 2.0                    162,438.6 162,438.6        Moved (from Table 1) 26.29(c)(2): Complete annual refresher training on FFD policy Not included in clearance (was in Table 1 but zero programs)        103,932.7                  1.5      155,899.0 155,899.0        Updated 26.31(b)(1)(i): Individual applying for access to serve as FFD program personnel provides background check
 
information for the background investigation, credit and
 
criminal history checks, and psychological assessment          93,890.0                  1.0          93,890.0              335.0                  1.0            335.0 (93,555.0)
Removed 26.31(d)(6): Donor provides written permission to conduct another analysis or test with specimen                  8.0                  1.0                  8.0 Removed (not an information collection)
(8.0)
Updated 26.35(a): Employee assistance program (EAP) records                  14.0                32.0              448.0                26.0                32.0            832.0 384.0 Updated 26.35(c): Individual completes and provides the EAP with a written waiver of right to privacy to share information with
 
FFD management            5,636.0                  0.3            1,690.8            1,039.3                0.25            259.8 (1,431.0)
Updated 26.35(c): Record of EAP disclosure to FFD management about an individual that poses an immediate hazard                15.0                  1.0                15.0                13.0                  1.0              13.0 (2
.0)
Updated 26.37(b): Individuals provide signed consent for release of information            1,127.0                  0.3              338.1              258.0                0.25              64.5 (273.6)
Updated 26.37(b)(1): Individual provides signed designation of personal representative for an FFD matter              961.0                  1.0              961.0              258.0                0.25              64.5 (896.5
)
Updated 26.37(d): Request by donor or donor's presentative to the licensee or other entity to provide personal records collected
 
under Part 26              961.0                  1.0              961.0                26.0 0.25              6.5                (954.5)
Updated 26.53(h): Applicant provides written consent before any actions are initiated under Subpart C of Part 26          93,890.0                  0.3          28,167.0          81,219.3                0.25        20,304.8 (7,862.2)
Updated 26.55(a)(1) - (a)(2): Initial authorization 26.57(a)(1) - (a)(2): Authorization update
 
26.59(a)(1) - (a)(2): Authorization reinstatement
 
Each individual applying for authorization must complete a
 
self-disclosure, employment history, and suitable inquiry Burden accounted for under sections 26.61 and 26.63 Burden accounted for under sections 26.61(a) and 26.63(a),(c) and (e)
-
Updated 26.59(c)(1): Applicant prepares self-disclosure (for authorization reinstatement period of interruption of no more
 
than 30 days)
Burden accounted for under section 26.61 Burden accounted for under sections 26.61(a)
-
Updated 26.61(a): Applicant prepares self-disclosure and employment history          93,890.0                  1.0          93,890.0          81,219.3                  1.0        81,219.3 (12,670.7)
Updated 26.63(a), (c), and (e): Former employer(s) provide information to the licensee or other entity to verify an
 
applicant's suitable inquiry information on previous
 
authorization(s)          93,890.0                0.80          75,112.0          81,219.3                0.75        60,914.5 (14,197.5)
Updated 26.63(c)(2): U.S. Department of Defense (DOD) provides licensee or other entity with form DD 214 which details an
 
applicant's military service record Burden of supplying DD 214 affects DOD Burden of supplying DD 214 affects DOD, or is accounted for under section 26.61(a) (if supplied by the applicant)
-
Updated 26.63(c)(3): Former employer refuses to provide information to the licensee or other entity about an applicant's prior
 
employment history              180.0                  0.5                90.0              180.0                  0.1              15.0 (75.
: 0)
Updated 26.67: Records of random D&A testing of persons who have applied for authorization, but who have not been granted
 
unescorted access authorization              335.0                  0.5              167.5              406.1                  0.5            203.0 35.55 Updated 26.69(b) and (c)(1): Applicant provides written self-disclosure and employment history to the licensee or other
 
entity (for authorization following a 1st or 2nd positive drug
 
or alcohol test result, or if other PDI is identified)
Burden accounted for under section 26.63 Burden accounted for under section 26.61(a)
-
Updated 26.69(c)(2): Former employer(s) of an applicant provide response to licensee or other entity request to confirm
 
suitable inquiry information for an applicant with PDI              939.0                  2.0            1,878.0              812.2                  2.0          1,624.4 (253.6)
Updated 26.85(c): Alternative collectors not employed by licensee provide proof of qualification                22.0                  1.0                22.0                26.0                  1.0              26.0 4.
0 Updated 26.85(e): Maintain personnel files for alternative collectors                22.0                  4.0                88.0                26.0                  4.0            104.0 16.
0 Approved Clearance Values (approved 11/30/14 - ICR 201407-3150-007)
Extension (2017-2020)
Table 4: Annual Third-Party Disclosure Burden Estimate Change Page 16 of 24 FINAL Supporting Statement, 10 CFR Part 26 Index Key:- Consolidated- Duplicative
- Moved
- New
- Removed
- Updated Section Number of Responses Burden Hours per Response Total Annual Burden Hours Number of Responses Burden Hours per Response Total Annual Burden Hours Approved Clearance Values (approved 11/30/14 - ICR 201407-3150-007)
Extension (2017-2020)
Table 4: Annual Third-Party Disclosure Burden Estimate Change Consolidated (in Table 2) 26.87(f)(1), and (f)(3) - (f)(5): Post a sign outside the collection area (if a public restroom) and document on the
 
custody-and-control form (CCF) the name of a same gender
 
observer (in the exceptional event that a designated
 
collection site is inaccessible, the collector is not the same
 
gender as the donor and a urine specimen must be
 
immediately collected)                  2.0                  1.0                  2.0  Consolidated in Table 2 (2.0)
Updated 26.89(a): Record that a donor did not appear for testing (no n licensee collection site)                  2.0                  1.0                  2.0                  2.0                  1.0                2.
0 -
Updated 26.89(b)(3): Record  FFD management informed that an individual did not present identification (non-licensee
 
collection site)                  2.0                  1.0                  2.0                  2.0                  1.0                2.
0 -
Updated 26.89(c): Record that FFD management informed that a donor refused to cooperate with the collection procedures (non-licensee collection site)                  2.0                  1.0                  2.0                    -                  0.25                  -  (2.0)
Updated 26.91(e)(4): Record that results cancelled after EBT calibration check failure (non-licensee collection site)                  1.0                  1.0                  1.0                    -                    1.0                  -  (1.0)
Updated 26.91(e)(5): Prepare record of EBT maintenance (non-licensee collection site)                22.0                  4.0                88.0                26.0                  4.0            104.0 16.
0 Updated 26.93(a)(6): Document alcohol pre-test questions asked and answered (non-licensee collection site)              280.0                  0.3                84.0              260.0                0.25              65.0 (19.0
)
Updated 26.95(b)(5): Record donor identity for initial alcohol breath test (non-licensee collection site)              280.0                  0.3                84.0              260.0                0.25              65.0 (19.0
)
Updated 26.97(b)(2): Record reason for new oral fluid alcohol test (non-licensee collection site)                  8.0                  0.5                  4.0                    -                    0.5                  -  (4.0)
Updated 26.97(c)(1): Document reason for failure of second collection attempt (non-licensee collection site)                  1.0                  1.0                  1.0                    -                    1.0                  -  (1.0)
Updated 26.97(d): Record results and alcohol screening device used (non-licensee collection site)                  8.0                  0.3                  2.4                    -                  0.25                  -  (2.40)
Duplicative Burden 26.99(b): Record test time of initial test with 0.02 percent BAC or higher (non-licensee collection site)                  1.0                  0.3                  0.3 Burden accounted for under section 26.715(b)(2)
(0.30)
Duplicative Burden 26.101(b)(7): EBT printout of confirmatory alcohol test result includes time of test (non-licensee collection site)                  1.0                  0.3                  0.3 Burden accounted for under section 26.715(b)(2)
(0.30)
Updated 26.103(b): Collector informs FFD management of result between 0.01 and 0.02 percent BAC when donor in work
 
status 3 or more hours (non-licensee collection site)                    -                    0.5                    -                      -                  0.25                  -  -
Duplicative Burden 26.107(b): Collector documents tampering attempt on CCF form (non-licensee collection site)                    -                    1.0                    -
Burden accounted for under section 26.111(b)
-
Updated 26.109(b)(3): Collector documents on CCF sh- bladder situation and notifies FFD management (non-licensee
 
collection site)                    -                    0.5                    -                      -                  0.25                  -  -
Updated 26.109(b)(4): Collector documents on CCF confirmation from FFD management to conduct a an observed collection (non-licensee collection site)                    -                    0.3                    -                      -                  0.25                  -  -
Updated 26.111(b): Collector documents on CCF if specimen characteristics (color, clarity) indicate possible tampering by
 
the donor (non-licensee collection site)                  2.0                  0.5                  1.0                    -                  0.25                  -  (1.0)
Updated 26.111(c): Collector documents on CCF unusual specimen temperature and/or other observations made during the
 
collection of possible tampering attempt and notifies FFD
 
management (non-licensee collection site)                      -                    0.4                    -                  0.25                  -  -
Duplicative Burden 26.113(b)(3): Collector completes CCF for split-specimen collection (non-licensee collection site)                    -                    0.3                    -
Burden accounted for under section 26.117(c) - (e)
-
Updated 26.115(b): Collector documents on CCF approval from FFD manager or MRO to collect a specimen under direct
 
observation (non-licensee collection site)                    -                    0.3                    -                      -                  0.25                  -  -
Updated 26.115(d): Collector documents on CCF directly observed collection performed and the reason for the observed
 
collection (non-licensee collection site)                    -                    0.3                    -
Burden accounted for under section 26.115(b)
-
26.115(f)(3): Record of name of observer (non-licensee collection site)                    -                    0.3                    -                      -                  0.25                  -  -
Updated 26.117(c) - (e): Collector prepares ID labels and CCF forms for specimen shipment (non-licensee collection site)              280.0                  0.3                84.0              260.0                0.25              65.0 (19.0
)
Updated 26.119(a), (e), and (f): Physician evaluating shy-bladder claim prepares report of medical examination of donor and
 
provides this information to the MRO                    -                    6.0                    -                  13.0                  2.0              2 6.0 26.0 Consolidated (in Table 2) 26.119(b): MRO provides information to physician as background for evaluation of a shy bladder claim                    -                    2.0                    -    Consolidated in Table 2 -
Updated 26.129(b): Collector prepares memorandum to and sends to LTF documenting investigation of discrepancies between
 
bottles and CCF (non-licensee collection site)                    -                    1.0                    -                    1.0                  -  -
Page 17 of 24 FINAL Supporting Statement, 10 CFR Part 26 Index Key:- Consolidated- Duplicative
- Moved
- New
- Removed
- Updated Section Number of Responses Burden Hours per Response Total Annual Burden Hours Number of Responses Burden Hours per Response Total Annual Burden Hours Approved Clearance Values (approved 11/30/14 - ICR 201407-3150-007)
Extension (2017-2020)
Table 4: Annual Third-Party Disclosure Burden Estimate Change Updated 26.135(b): Donor request to MRO for the retesting of an aliquot of a single specimen or the testing of the Bottle B
 
split specimen at a second HHS lab (initial specimen testing
 
performed at an LTF)                    1.0                  0.5                  0.5 Burden accounted for under section 26.165(b)(1)
(0.50)
Removed 26.137(b)(3): LTF records submitting 1 in 10 negative specimens for validity screening to HHS lab                    -                  40.0                    -
Not Third Party Burden (accounted for in Table 2)
-
Updated 26.153(g): Supply memorandum to HHS lab explaining use of non-federal CCF form (non-licensee collection site)                  2.0                  0.5                  1.0                  2.0                  0.5                1.
0 -
Updated 26.155(a)(1): Document of HHS lab manager qualifications Burden covered by HHS lab certification requirements OMB Clearance # 0930-0158 Burden covered by HHS lab certification requirements OMB Clearance No. 0930-0158
-
Updated 26.155(a)(3): HHS lab personnel training documentation Burden covered by HHS lab certification requirements OMB Clearance # 0930-0158 Burden covered by HHS lab certification requirements OMB Clearance No. 0930-0158
-
Updated 26.155(a)(4): HHS lab manager reviews and approved lab procedures Burden covered by HHS lab certification requirements OMB Clearance # 0930-0158 Burden covered by HHS lab certification requirements OMB Clearance No. 0930-0158
-
Updated 26.155(a)(5): HHS lab manager maintains QA program Burden covered by HHS lab certification requirements OMB Clearance # 0930-0158 Burden covered by HHS lab certification requirements OMB Clearance No. 0930-0158
-
Updated 26.155(b): Certifying scientist at HHS lab certifies test results Burden covered by HHS lab certification requirements OMB Clearance # 0930-0158 Burden covered by HHS lab certification requirements OMB Clearance No. 0930-0158
-
26.155(c): Supervise technical analysts at HHS lab Burden covered by HHS lab certification requirements OMB Clearance # 0930-0158 Burden covered by HHS lab certification requirements OMB Clearance No. 0930-0158
-
Updated 26.155(e): Continuing education of HHS lab staff Burden covered by HHS lab certification requirements OMB Clearance # 0930-0158 Burden covered by HHS lab certification requirements OMB Clearance No. 0930-0158
-
Updated 26.155(f): HHS lab personnel records Burden covered by HHS lab certification requirements OMB Clearance # 0930-0158 Burden covered by HHS lab certification requirements OMB Clearance No. 0930-0158
-
Updated 26.157(a): Written HHS lab procedures for accession, receipt, shipment, and testing of urine specimens Burden covered by HHS lab certification requirements OMB Clearance # 0930-0158 Burden covered by HHS lab certification requirements OMB Clearance No. 0930-0158
-
26.157(b): Written HHS lab chain-of-custody procedures for HHS lab Burden covered by HHS lab certification requirements OMB Clearance # 0930-0158 Burden covered by HHS lab certification requirements OMB Clearance No. 0930-0158
-
Updated 26.157(c): Written HHS lab procedures for each testing assay performed Burden covered by HHS lab certification requirements OMB Clearance # 0930-0158 Burden covered by HHS lab certification requirements OMB Clearance No. 0930-0158
-
Updated 26.157(d): Written HHS lab procedures for device set-up and operation Burden covered by HHS lab certification requirements OMB Clearance # 0930-0158 Burden covered by HHS lab certification requirements OMB Clearance No. 0930-0158
-
Updated 26.157(e): Written HHS lab procedures for remedial actions to address system and instrument errors Burden covered by HHS lab certification requirements OMB Clearance # 0930-0158 Burden covered by HHS lab certification requirements OMB Clearance No. 0930-0158
-
Updated 26.159(a): Retain records (e.g., an access log) of authorized visitors, maintenance personnel, and service personnel who
 
accessed secure areas of HHS lab Burden covered by HHS lab certification requirements OMB Clearance # 0930-0158 Burden covered by HHS lab certification requirements OMB Clearance No. 0930-0158
-
NEW 26.159(b)(1): Record that the HHS lab notified the licensee or other entity within 24 hours of identifying evidence of
 
specimen tampering Not included in previous clearance  0                1.0                  -
Updated 26.159(c) - (e): Use and storage of CCF forms at HHS lab Burden covered by HHS lab certification requirements OMB Clearance # 0930-0158 Burden accounted for under section 26.715(b)(2)
-
Updated 26.159(f): Use of CCF by HHS lab when shipping a specimen to another HHS lab Burden covered by HHS lab certification requirements OMB Clearance # 0930-0158 Burden accounted for under section 26.165(b)(1)
-
Updated 26.165(b)(1): At the direction of the MRO, the initial HHS lab that conducted testing send a donor's specimen (i.e., an
 
aliquot of a single specimen or Bottle B of the split
 
specimen) to a second HHS lab for further testing                  1.0                  1.0                  1.0                31.1                  1.0              31.1 30.1 Consolidated (in Table 2) 26.165(b)(2): Record that MRO informed the donor of the opportunity to request the retesting of an aliquot of a single
 
specimen or the testing of the Bottle B split specimen at a
 
second HHS lab                  1.0                  0.3                  0.3 Consolidated in Table 2(0.30)
Updated 26.165(b)(3): Donor provides written request to the MRO for the retesting of an aliquot of a single specimen or the testing


of the Bottle B split specimen                    1.0                  1.0                  1.0                31.1                  1.0              31.1 30.1 Duplicative Burden 26.165(b)(4): Donor presents documentation to the MRO on the reason for not being able to make a timely retest request                    -                    1.0                    -
FINAL Supporting Statement, 10 CFR Part 26 Approved Clearance Values                                    Extension Table 1: One Time Recordkeeping                                                    (approved 11/30/14 - ICR 201407-3150-007)                          (2017-2020)
Burden accounted for under section 26.185(e)
Index Key:                                                                                                                                                                                   Burden
-
- Updated                                                                                                                                                                                    Estimate Number of        Burden Hrs              Total      Number of        Burden Hrs                  Total
Page 18 of 24 FINAL Supporting Statement, 10 CFR Part 26 Index Key:- Consolidated- Duplicative
- Duplicative Section                                                        Record-    per Recordkeeper        Burden Hrs    Record-    per Recordkeeper            Burden Hrs      Change
- Moved
- Moved
- New
- New                                                                           keepers        (Annualized)        (Annualized)    keepers        (Annualized)            (Annualized)
- Removed
- Removed Updated    26.27(a): Develop FFD policy statement                                  0                107.0                -          0                    112.0                  -          -
- Updated Section Number of Responses Burden Hours per Response Total Annual Burden Hours Number of Responses Burden Hours per Response Total Annual Burden Hours Approved Clearance Values (approved 11/30/14 - ICR 201407-3150-007)
Updated    26.27(a): Develop FFD procedures                                        0                213.0                -         0                    212.0                  -          -
Extension (2017-2020)
Updated   26.29(a) and (b): Develop FFD training course and exam                  0                  96.3                -         0                    100.0                  -           -
Table 4: Annual Third-Party Disclosure Burden Estimate Change Duplicative Burden 26.165(b)(6) HHS lab provides report to the MRO of the quantitative test results of the retesting of aliquot of a single
Moved    26.29(b): All current staff take FFD exam and FFD exam                                                                              Moved to Table 4 0                400.4                -                                                                  -
 
(to Table 4) graded                                                                                                                      (Third-Party Disclosure Burden)
specimen or the testing of the Bottle B split specimen                  1.0                 0.5                   0.5 Burden accounted for under section 26.185(n)
Moved                                                                                                                                        Moved to Table 4 26.29(c)(2): FFD training for current staff                              0              4,710.7                -                                                                  -
(0.50)
(to Table 4)                                                                                                                              (Third-Party Disclosure Burden) 26.31(b)(1)(v): Develop behavioral observation program Updated                                                                    Burden accounted for under 26.27 (0 programs)            Burden accounted for under 26.27(a)                        -
Updated 26.167(a): HHS lab documents QA program (encompasses all aspects of the testing process)
(BOP) procedures 26.31(d)(1)(i)(C): Develop rigorous testing procedures to ensure that the MRO can evaluate the use of substances NEW                                                                            Not included in previous clearance                Burden accounted for under 26.27(a) not included in the NRC-required testing panel (if additional substance testing is performed) 26.31(d)(1)(i)(D) and (d)(1)(ii): Documentation of forensic Moved    toxicologist review and certification of additional drug(s) to        Previously accounted for in Table 2 3.0                       5.3                16.0       16.0 (from Table 2) be included in the licensee or other entity's drug testing                   as Annualized Burden panel Duplicative                                                                                                                              Burden accounted for in section 26.31(d)(1)(iii): Document additional drugs in testing panel            0                  0.3                -                                                                  -
Burden covered by HHS lab certification requirements OMB Clearance # 0930-0158 Burden covered by HHS lab certification requirements OMB Clearance No. 0930-0158
Burden                                                                                                                                26.31(d)(3)(iii)(A) and (d)(3)(iii)(C) 26.31(d)(3)(iii)(A) and (d)(3)(iii)(C): Documentation of Moved    forensic toxicologist review and certification of lower drug          Previously accounted for in Table 2 3.0                      5.3                16.0      16.0 (from Table 2) testing cutoff levels than specified by Part 26, and                        as Annualized Burden inclusion of cutoff levels in the FFD policy and procedures 26.37(a): Develop a system of files and procedures to Updated                                                                            0                  2.7                -         0                    24.0                  -          -
-
protect personal information collected under Part 26 REMOVED REMOVED      26.37(b): Obtain signed consent for release of information              0                  98.1                -                                                                  -
26.167(c)(2)(i): Refractometer at the HHS lab must display specific gravity to 4 decimals and be interfaced with
[covered by Table 2 - 26.37(b)]
 
26.39(a) and (b): Develop procedures for the review of a Updated                                                                            0                  13.3                -          0                    120.0                  -          -
laboratory information management system or computer
determination that an individual has violated the FFD policy Updated    26.85(a): Develop urine collector qualification training                0                  5.3                -          0                    13.3                  -          -
 
Updated    26.85(b): Develop alcohol collector qualification training              0                  5.3                -         0                      5.3                  -           -
and/or document result by hard copy or electronic display Burden covered by HHS lab certification requirements OMB Clearance # 0930-0158 Burden covered by HHS lab certification requirements OMB Clearance No. 0930-0158
26.127(a) - (e): Develop LTF procedures for specimen handling and chain-of-custody, assays performed, Updated                                                                            0                  80.0                -          0                    80.0                  -          -
-
instrument and test setup, and remedial actions for systems and testing devices 26.137(a): Develop LTF procedures for quality assurance/
Updated 26.167(f)(3): False positive error on BPTS test and the error is technical or methodological, the HHS lab Responsible
Updated                                                                            0                  13.3                -          0                    13.3                  -          -
 
quality control (QA/QC) program Moved    26.153(e): Record of pre-award inspection of new HHS lab              Previously accounted for in Table 2 3.0                      13.3                40.0      40.0 (from Table 2) (completed prior to awarding contract for testing services)                  as Annualized Burden 26.153(f): Record that Part 26 specified requirements Moved                                                                            Previously accounted for in Table 2 included in a licensee's or other entity's contract with a new                                                          3.0                      13.3                40.0      40.0 (from Table 2)                                                                              as Annualized Burden HHS lab 26.155(a)(1), (a)(3) - (a)(5); (b),(c), (e), and (f):
Person must document that retesting of all positive, adulterated, substituted, and invalid specimens from the
Confirm HHS lab personnel qualifications and procedures Updated                                                                            0                  2.7                -      Burden accounted for under 26.153(e)                      -
 
place pursuant to HHS laboratory certification also meet Part 26 requirements (new HHS lab) 26.157(a) - (e): Confirm HHS lab procedures in place for accession, receipt, shipment, and testing of specimens Updated                                                                            0                  2.7                -       Burden accounted for under 26.153(e)                      -
time of final resolution of the error back to the time of the
pursuant to HHS laboratory certification also meet Part 26 requirements (new HHS lab) 26.159(a), (c), (e), (f): Confirm HHS lab procedures for specimen security, chain of custody, and preservation in Updated    place pursuant to HHS laboratory certification                           0                  2.7                -       Burden accounted for under 26.153(e)                      -
 
requirements also meet Part 26 requirements (new HHS lab) 26.203(a): Prepare fatigue management policy (In addition 2.0                  7.3              14.6          0                      7.3                  -      (14.6) to 26.27 burden) 26.203(b): Prepare fatigue management procedures (in 2.0                  1.7              3.4          0                      1.7                  -        (3.4) addition to 26.27 burden) 26.203(c): Prepare training on fatigue management.                    2.0                  2.0              4.0          0                      2.0                  -        (4.0) 26.205(b): Develop work hour tracking system                          2.0                  7.7              15.4          0                      7.7                  -      (15.4) 26.205(c): Develop individual work scheduling system                  2.0                  2.0              4.0          0                      2.0                  -        (4.0) 26.401(b): Prepare a reactor construction site D&A testing                                                                    Burden accounted for under Updated                                                                            0                  60.0                -                                                                  -
last satisfactory performance test cycle has been
program plan                                                                                                                    section 26.403(a) and (b) 26.403(a): Develop FFD policy statement Updated                                                                            0                107.0                -          0                    112.0                  -          -
 
(reactor construction site D&A testing program)
completed, as requested by the licensee or other entity Burden covered by HHS lab certification requirements OMB Clearance # 0930-0158                    -                    8.0                  -   -
Moved    26.403(a): Distribute FFD policy statement to subject 0                  5.0                -                  Moved to Table 2                                -
Updated 26.167(h): HHS lab labels standards and controls Burden covered by HHS lab certification requirements OMB Clearance # 0930-0158 Burden covered by HHS lab certification requirements OMB Clearance No. 0930-0158
(to Table 2) individuals (reactor construction site D&A testing program) 26.403(b): Develop written FFD procedures Updated                                                                             0                213.0                -          0                    216.0                  -          -
-
(reactor construction site D&A testing program)
Updated 26.168(a): Blind performance test sample (BPTS) supplier provides HHS lab certification letter of BPTS formulation to
Moved    26.405(d): Record of testing for specified drugs,                      Previously accounted for in Table 2 Burden accounted for under section 26.403(a)                -
(from Table 2) adulterants, and alcohol, at Part 26 specified cutoff levels                as Annualized Burden 26.405(e): Develop specimen collection and D&A testing procedures to protect the donor's privacy, integrity of the            Previously accounted for in Table 2 NEW                                                                                                                            Burden accounted for under section 26.403(b) specimen, and stringent quality controls to ensure accurate                  as Annualized Burden test results Page 4 of 24


licensee or other entity Burden covered by HHS lab certification requirements OMB Clearance # 0930-0158                  2.0                  8.0              16.0 16.0 Updated 26.168(h)(2): BPTS sample supplier provides expiration date on each BPTS Burden covered by HHS lab certification requirements OMB Clearance # 0930-0158                  2.0                  8.0              16.0 16.0 Moved (to Table 2) 26.168(i)(2): Licensee or other entity completes CCF for a BPTS, places fictional initials on specimen labels, and
FINAL Supporting Statement, 10 CFR Part 26 Approved Clearance Values                                    Extension Table 1: One Time Recordkeeping                                                  (approved 11/30/14 - ICR 201407-3150-007)                           (2017-2020)
 
Index Key:                                                                                                                                                                                   Burden
indicates on the MRO copy of the CCF that the specimen is
- Updated                                                                                                                                                                                   Estimate Number of       Burden Hrs              Total      Number of       Burden Hrs                 Total
 
- Duplicative Section                                                        Record-    per Recordkeeper        Burden Hrs    Record-     per Recordkeeper          Burden Hrs        Change
a BPTS  Burden covered by HHS lab certification requirements OMB Clearance # 0930-0158  Moved to Table 2 -
Updated 26.169(a): HHS lab reports test results to the MRO of the licensee or other entity Burden covered by HHS lab certification requirements OMB Clearance # 0930-0158 Burden accounted for under section 26.169(c)(1)
-
Updated 26.169(c)(1): HHS lab provides record to the MRO for each positive, adulterated, substituted, dilute, and invalid test
 
result              686.0                0.25              171.5              621.0                0.25            155.3 (16.3)
Duplicative Burden 26.169(c)(2): HHS lab provides quantitative test result record for positive drug test (at the request of the MRO)                  5.0                  1.0                  5.0 Burden accounted for under section 26.169(c)(1)
(5.0)
Duplicative Burden 26.169(c)(2): HHS lab record of quantitative test results for opiates to the MRO (at the request of the MRO)                16.0                  1.0                16.0 Burden accounted for under section 26.169(c)(1)
(16.0)
Duplicative Burden 26.169(c)(3): HHS lab provides quantitative test result record for adulterated or substituted test results (at the
 
request of the MRO)                  5.0                  1.0                  5.0 Burden accounted for under section 26.169(c)(1)
(5.0)
Updated 26.169(c)(4): HHS lab record of contact with MRO to discuss if additional testing by another HHS lab should be
 
conducted on a specimen with an invalid test result                10.0                  0.5                  5.0                10.0                  0.5                5.0
-
Updated 26.169(f): HHS lab transmits to the MRO a copy of CCF for specimens with negative test results Electronic transmission Burden accounted for under section 26.715(b)(2)
-
Duplicative Burden 26.169(g): HHS lab transmits to the MRO a copy of the original CCF signed by the certifying scientist (for positive, adulterated, substituted, dilute and invalid test result)              686.0                  0.5              343.0 Burden accounted for under section 26.169(c)(1)
(343.0)
Updated 26.169(h): HHS lab prepares and submits annual statistical summary report of urinalysis testing results                10.0                40.0              400.0                67.0                 2.0            134.0 (266.
: 0)
Consolidated (in Table 2) 26.183(a): Documentation of MRO qualifications                28.0                  1.0                28.0 Consolidated in Table 2(28.0)
Consolidated (in Table 2) 26.183(c)(1): MRO review of records for positive, adulterated, substituted, invalid, or, at the licensees or other
 
entity's discretion, dilute test results that confirm as an FFD
 
violationBurden accounted for under section 26.185(a) Consolidated in Table 2-Consolidated (in Table 2) 26.183(d)(2)(i): Record of MRO staff review and reporting of negative test results          16,383.0                  0.1              819.2 Consolidated in Table 2(819.15)
Consolidated (in Table 2) 26.183(d)(2)(ii): Record of MRO staff review of CCF forms and forward changes to MRO                54.0                  0.1                  5.4 Consolidated in Table 2(5.40)
Consolidated (in Table 2) 26.185(a) Record of MRO review of all positive, adulterated, substituted, or invalid test results and report to licensee or
 
other entity              635.0                  1.0              635.0 Consolidated in Table 2(635.0)
Updated 26.185(c): Donor discussion with MRO of positive, adulterated, substituted, dilute, or invalid test result              635.0                  1.0              635.0 621.0                              0.5            310.5 (324.5)
Page 19 of 24 FINAL Supporting Statement, 10 CFR Part 26 Index Key:- Consolidated- Duplicative
- Moved
- Moved
- New
- New                                                                           keepers        (Annualized)        (Annualized)    keepers        (Annualized)          (Annualized)
- Removed
- Removed 26.406(a), (b), and (d): Develop a fitness monitoring Updated   program (applies if reactor construction site D&A testing              0                  26.7                -           0                    40.0                    -         -
- Updated Section Number of Responses Burden Hours per Response Total Annual Burden Hours Number of Responses Burden Hours per Response Total Annual Burden Hours Approved Clearance Values (approved 11/30/14 - ICR 201407-3150-007)
program does not conduct random testing) 26.406(c): Develop procedures for fitness monitors Updated    (applies if reactor construction site D&A testing program              0                  40.0                -           0                    40.0                    -        -
Extension (2017-2020)
does not conduct random testing) 26.407: Develop procedures for behavioral observation Updated                                                                            0                  40.0                -          0                    40.0                    -        -
Table 4: Annual Third-Party Disclosure Burden Estimate Change Consolidated (in Table 2) 26.185(d)(1): Documentation that donor declined to discuss test results                 81.0                  1.0                 81.0 Consolidated in Table 2(81.0)
(reactor construction site D&A testing program) 26.411(a): Develop procedures for maintaining a system of NEW      files to protect personal information collected under                 Not included in previous clearance                    0                    40.0                    -
Updated 26.185(e): Donor provides documentation to the MRO demonstrating an inability to discuss test results and
Subpart K of Part 26 26.413: Develop procedures for the review of a Updated    determination that an individual violated the FFD policy          0                    120.0                  -          0                  120.0                   -        -
(reactor construction site D&A testing program) 26.713(g): Documentation on testing for additional drugs Burden accounted for under Moved    as permitted under section 26.31(d)(1), use of more                  Previously accounted for in Table 2 section 26.31(d)(1)(i)(D) and (d)(1)(ii), and (from Table 2) stringent testing cutoff levels as permitted under section                  as Annualized Burden section 26.31(d)(3)(iii)(A) and (d)(3)(iii)(c) 26.31(d)(3), or both.
Table 1: Total                                                41.4                                                    112.0      70.6 Page 5 of 24


requesting the test result determination be reopened                  8.0                 1.0                   8.0                   8.0                 1.0                 8.
Final Supporting Statement, 10 CFR Part 26 Approved Clearance Values                            Extension Table 2: Annual Recordkeeping                                                    (approved 11/30/14 - ICR 201407-3150-                    (2017-2020)
0 -
Index Key:
Updated 26.185(f)(1): HHS lab consultation with MRO on whether additional testing of a specimen with an invalid test result
Burden
- New                                                                                                            Total                      Burden          Total Number of        Burden                    Number of                                  Estimate
- Updated                                                                                                        Annual                    Hours per      Annual Section                                                          Record-        Hours per                    Record-                                    Change
- Moved                                                                                                          Burden                      Record-        Burden keepers    Recordkeeper                    keepers
- Duplicative                                                                                                    Hours                        keeper        Hours
- Removed 26.4(j):For personnel granted authorization by a licensee, who are covered by the D&A testing program regulated by a State or Federal agency - (1) record of training that Updated                                                                          30.5                2.0        61.0          33.5          2.0          67.0        6.0 demonstrates section 26.29(a) training requirements met (if not already covered by the program); (2) record of notice of any FFD policy violation 26.27(b): Make FFD policy statement readily available to Updated                                                                          28.0                4.0        112.0          26.0          16.0          416.0      304.0 subject personnel Updated    26.27(c): Updates to FFD policy and procedures                        28.0                8.0        224.0          26.0          80.0        2,080.0    1,856.0 26.27(d): Provide FFD policy and procedures to NRC for Updated                                                                          28.0                4.0        112.0          26.0          4.0          104.0        (8.0) review (performed during periodic inspections) 26.29(b): Record of training completion (initial training on Updated                                                                          28.0                2.0        56.0          26.0        104.1        2,707.3    2,651.3 FFD policy) and results of comprehensive examination 26.29(c)(2): Record of training completion (annual refresher Updated                                                                          28.0                2.0        56.0          26.0        133.2        3,464.4    3,408.4 training on FFD policy) 26.29(d): Record acceptance of FFD training from other 28.0                4.0        112.0          26.0          4.0          104.0        (8.0) licensees' programs 26.31(b)(1)(i): Records of background investigations, credit and criminal history checks, and psychological assessments Updated                                                                          28.0                17.5        490.0          26.0          16.0          416.0      (74.0) of checks for performed on individuals designated as FFD personnel Duplicative 26.31(b)(1)(v): Record results of behavioral observation for                                                      Burden accounted for under 28.0                80.0      2,240.0                                                (2,240.0)
Burden    FFD program personnel                                                                                                    section 26.189(c) 26.31(d)(1)(i)(D): Document analysis and certification for Moved testing of drugs not included in the NRC minimum testing                2.3                4.0           9.2            Moved to Table 1                      (9.2)
(to Table 1) panel Moved 26.31(d)(2)(ii): Document licensee additions to tested drugs            2.3                8.0         18.4              Moved to Table 1                    (18.4)
(to Table 1) 26.31(d)(3)(ii): Document LTF technician qualifications to                                                        Burden accounted for under NEW                                                                                Not included in clearance perform validity and drug tests.                                                                                    section 26.125(b) and (c)
Moved 26.31(d)(3)(iii)(A): Document more stringent cutoff levels              2.0                8.0         16.0              Moved to Table 1                     (16.0)
(to Table 1)
Moved    26.31(d)(3)(iii)(C): Document evaluation and certification of 2.0                8.0        16.0              Moved to Table 1                    (16.0)
(to Table 1) more stringent cutoff levels Removed.
26.31(d)(6): Donor provides written permission to conduct                                                    This is a testing limitation provision and REMOVED                                                                              -                1.0             -                                                     -
another analysis or test on a specimen                                                                          does not have a corresponding recordkeeping or reporting burden.
Duplicative                                                                                                                    Burden accounted for under 26.33: Behavioral observation records                                28.0              400.0      11,200.0                                              (11,200.0)
Burden                                                                                                                            section 26.189(c)
Moved 26.35(a): Employee assistance program (EAP) records                  28.0                16.0        448.0              Moved to Table 4                    (448.0)
(to Table 4) 26.35(c): Record of written waiver of right to privacy from Updated                                                                          28.0                2.0        56.0            13.0          2.0          26.0      (30.0) individuals given to the Employee Assistance Program (EAP) 26.35(c): Record of EAP disclosure to a licensee or other Updated   entity that an individual poses an immediate hazard, or who          14.0                1.0        14.0            13.0          1.0          13.0        (1.0) has waived in writing the right to privacy 26.37(b)(1): Record of signed consent from individual to Updated    disclose information collected under Part 26 to the                  28.0                40.0      1,120.0          26.0          2.5          64.5    (1,055.5) individuals representative on an FFD matter 26.37(c): Record of signed release from subject individual to Updated    disclose personal information collected under Part 26 to other        28.0                40.0      1,120.0          26.0          40.0        1,040.0      (80.0) licensees or other entities 26.37(d): FFD management provides records to individual on Updated                                                                          28.0                40.0      1,120.0          26.0          40.0        1,040.0      (80.0) an FFD violation Duplicative 26.39(a): Maintain procedures for the review of FFD violation                                                      Burden accounted for under 28.0                40.0      1,120.0                                                (1,120.0)
Burden    determinations                                                                                                            section 26.27(c) 26.39(b): D&A testing program provides notice to an NEW      individual of the grounds of an FFD policy violation                      Not included in clearance                  26.0          87.3        2,270.6    2,270.6 determination and review procedures 26.39(d): If a review of an FFD violation finds in favor of the Updated    individual, the licensee or other entity updates records (delete      28.0                40.0      1,120.0            6.0          16.0          96.0    (1,024.0) or correct information found to be inaccurate) 26.39(e): C/V with a D&A testing program provides review Updated                                                                              -                0.5            -            1.0          0.5            0.5        0.5 procedures to each individual that has violated the FFD policy Burden accounted for under                Burden accounted for under 26.41(a), (b), and (c): Record of audits                                                                                                                        -
section 26.41(f)                      section 26.41(f) and (g) 26.41(d): Record of review of C/V audit results                      28.0                40.0      1,120.0          26.0          40.0        1,040.0      (80.0) 26.41(f): Document and report audit results                          28.0                40.0      1,120.0          26.0          40.0        1,040.0      (80.0)
Page 6 of 24


should be performed at a second HHS lab Burden accounted for under section 26.185(c)                 26.0                0.50              13.0 13.0 Updated 26.185(f)(2): Donor discussion with MRO regarding an invalid test result Burden accounted for under section 26.185(c)
Final Supporting Statement, 10 CFR Part 26 Approved Clearance Values                          Extension Table 2: Annual Recordkeeping                                                      (approved 11/30/14 - ICR 201407-3150-                  (2017-2020)
Burden accounted for under section 26.185(c)  
Index Key:
-
Burden
Updated 26.185(h)(1): Donor discussion with MRO regarding a substituted test result Burden accounted for under section 26.185(c)
- New                                                                                                                Total                  Burden          Total Number of        Burden                    Number of                                Estimate
Burden accounted for under section 26.185(c)  
- Updated                                                                                                          Annual                  Hours per      Annual Section                                                              Record-        Hours per                  Record-                                  Change
-
- Moved                                                                                                            Burden                  Record-      Burden keepers    Recordkeeper                  keepers
Consolidated (in Table 2) 26.185(h)(2): MRO notification to licensee that no valid medical explanation presentedBurden accounted for under section 26.185(c) Consolidated in Table 2-Consolidated (in Table 2) 26.185(h)(3): MRO notification to licensee that valid medical explanation presentedBurden accounted for under section 26.185(c) Consolidated in Table 2-Updated 26.185(i)(1): Donor discussion with MRO regarding an adulterated test result Burden accounted for under section 26.185(c)
- Duplicative                                                                                                      Hours                    keeper        Hours
Burden accounted for under section 26.185(c)  
- Removed 26.41(g): Sharing of audit reports - D&A testing programs may jointly conduct audits or accept audits of C/Vs and HHS Updated                                                                            28.0                40.0      1,120.0        26.0       40.0        1,040.0       (80.0) labs conducted by other D&A testing programs (if the audit addresses the same services utilized by each program) 26.53(e)(2): Record that C/Vs informed licensee of the denial Updated                                                                              1.0              120.0        120.0          1.0        13.0            13.0      (107.0) or termination of an individual's authorization 26.53(g): Record that CVs and other licensees informed of 7.0                8.0        56.0            0          8.0              -      (56.0)
-
Part 26 violations 26.53(h): Obtain and retain written consent from each Updated    individual before initiating any actions under Subpart C of              28.0            1,677.0    46,956.0        26.0      156.2        4,061.0  (42,895.0)
Consolidated (in Table 2) 26.185(i)(2): MRO notification to licensee that no valid medical explanation presentedBurden accounted for under section 26.185(c) Consolidated in Table 2-Consolidated (in Table 2)26.185(i)(3): MRO notification to licensee that valid medical explanation presented for an adulterated test resultBurden accounted for under section 26.185(c) Consolidated in Table 2-Updated 26.185(j) Donor discussion with MRO regarding a positive test result from use of a prescription medication (amphetamine, morphine, codeine), and donor provides
Part 26 26.53(i): Individual applying for authorization is informed in Updated   writing of the reason(s) for denial or termination of                    28.0                23.3        652.4        26.0        21.8          567.7      (84.7) authorization 26.55(a)(1) - (a)(2): Initial authorization 26.57(a)(1) - (a)(2): Authorization update Burden accounted for under sections 26.59(a)(1) - (a)(2): Authorization reinstatement                          Burden accounted for under Updated                                                                                                                        26.61(a), (a)(1), and (a)(2),              -
For each individual applying for authorization, a record of a              sections 26.61 and 26.63 and 26.63 (a), (c), and (e) completed self-disclosure, employment history, and suitable inquiry is maintained 26.59(c)(1): Obtain, review, and retain an applicants self-              Burden accounted for under              Burden accounted for under Updated                                                                                                                                                                    -
disclosure                                                                        section 26.61                section 26.61(a), (a)(1) and (a)(2) 26.61(a), (a)(1), and (a)(2): Obtain, review, and retain an Updated                                                                            28.0            1,197.0    33,516.0        26.0    1,561.9        40,609.7    7,093.7 applicants written self-disclosure and employment history 26.61(b) and (c): Specify the information to be collected in                                                        Burden accounted for under NEW                                                                                    Not included in clearance the self-disclosure and employment history                                                                      section 26.61(a), (a)(1) and (a)(2) 26.63(a), (c), and (e): Obtain, review, and retain an Updated                                                                            28.0            1,197.0    33,516.0        26.0    1,561.9        40,609.7    7,093.7 applicants suitable inquiry 26.63(c)(2): Obtain, review, and retain information on an Updated                                                                             28.0                4.0        112.0        26.0          4.0          104.0        (8.0) applicants U.S. military service (i.e., form DD 214) 26.63(c)(3): Document inability to obtain information from an Updated                                                                            28.0                2.7        75.6        26.0          3.0          78.0        2.4 applicants past employer(s) 26.63(d) and (e): Maintain documentation of denial or unfavorable termination of authorization from other FFD                  28.0                1.0        28.0        26.0          1.0          26.0        (2.0) programs 26.63(f): Specifies the time periods that a suitable inquiry Burden accounted for under NEW      must cover (for initial authorization, authorization update, and            Not included in clearance section 26.63(a), (c) and (e) authorization reinstatement) 26.65(d) and (e): Record of reinstatement or administrative 28.0                4.0        112.0        26.0          4.0          104.0        (8.0) withdrawal of authorization 26.65(f): Authorization reinstatement after an interruption --
Updated    record of administrative withdrawal of authorization under              28.0                1.0        28.0        26.0          1.0          26.0        (2.0) section 26.65(d)(1)(ii) or (e)(2)(iii)(B) 26.67 Record of random D&A testing of persons who have Duplicative                                                                                                                Burden accounted for under section applied for authorization and who have received a pre-access            28.0                5.5        154.0                                              (154.0)
Burden                                                                                                                                26.183(d)(2)(i) test, but who have yet to be granted authorization 26.69(b) and (c)(1): Authorization following a 1st or 2nd positive drug or alcohol test result, or if other PDI is identified        Burden accounted for under              Burden accounted for under Updated                                                                                                                                                                    -
              -- obtain, review, and retain an applicants self-disclosure and              section 26.713(a)(1)                      section 26.61(a) employment history 26.69(c)(2): Record that the licensee or other entity identified Updated    and resolved PDI (not reviewed and favorably resolved by a              28.0                40.0      1,120.0        26.0        62.5        1,624.4      504.4 previous licensee or other entity) 26.69(c)(3): Record that the licensee or other entity verified that an applicant with a prior FFD testing violation (i.e., a 5-                                                    Burden accounted for under Updated                                                                            28.0                40.0      1,120.0                                            (1,120.0) year denial for a 2nd positive result) has abstained from                                                              section 26.69(c)(4) substance abuse for at least 5 years 26.69(c)(4): Record that an SAE conducted a determination of fitness and concluded that an applicant with PDI is fit to safely and competently perform duties (i.e., evaluated clinically appropriate treatment and followup testing plans were developed by an SAE -- for an applicant with a prior 1st Updated                                                                            28.0                3.0        84.0        26.0        40.0        1,040.0      956.0 positive result; ensured treatment recommendations and followup testing from an SAEs determination of fitness are initiated -- for an applicant with a prior 2nd positive result; or verified the applicant is in compliance with and successfully completed any followup testing and treatment plans) 26.69(c)(5): Record of negative results for pre-access D&A Updated                                                                            28.0                1.0        28.0        26.0        52.1        1,353.7    1,325.7 testing (needed prior to granting authorization) 26.69(d): Record of reviewing officials determination on an Updated                                                                            28.0                24.0        672.0        26.0        24.0          624.0      (48.0) applicants request for access authorization Page 7 of 24


documentation on medication use to the MRO (e.g.,
Final Supporting Statement, 10 CFR Part 26 Approved Clearance Values                      Extension Table 2: Annual Recordkeeping                                                    (approved 11/30/14 - ICR 201407-3150-              (2017-2020)
prescription information and pharmacy, prescribing
Index Key:
 
Burden
physician information)
- New                                                                                                          Total                  Burden      Total Number of      Burden                    Number of                            Estimate
Burden accounted for under section 26.185(c)                 60.0                 1.0               60.0 60.0 Consolidated (in Table 2) 26.185(k):
- Updated                                                                                                      Annual                  Hours per    Annual Section                                                            Record-      Hours per                  Record-                              Change
MRO report to licensee that no FFD policy violation has occurred                  24.0                 1.0                 24.0 Consolidated in Table 2(24.0)
- Moved                                                                                                        Burden                  Record-    Burden keepers    Recordkeeper                  keepers
Consolidated (in Table 2) 26.185(m): MRO review of inspection and audit reports, quality control data, multiple specimens, and other data to
- Duplicative                                                                                                  Hours                  keeper      Hours
 
- Removed 26.69(e): Record that follow-up testing and treatment plan for an applicant from the D&A testing program of another Updated                                                                          28.0                8.0      224.0      26.0         8.0       208.0       (16.0) licensee or other entity has been verified (that is treatment and follow-up testing successfully completed) 26.69(e)(1): Record that information transmitted on testing Updated    and treatment plans to other FFD programs (at donor                    28.0                8.0      224.0      26.0         8.0       208.0       (16.0) request) 26.75(a) - (e), and (g): Records of sanctions for FFD                                                         Burden accounted for under Consolidated                                                                        28.0               12.0       336.0                                           (336.0) violations                                                                                                          section 26.39(b) 26.75(h): Record that an individuals authorization was administratively withdrawn due to impairment confirmed Updated                                                                          28.0               18.0       504.0       26.0         15.6        405.3      (98.7) under section 26.189, or because the individual posed a safety hazard 26.75(i): Record of temporary administrative withdrawal of an Updated    individual's authorization due to an initial positive test result     28.0               80.0   2,240.0      0              80.0             -  (2,240.0) for marijuana and/or cocaine at an LTF 26.75(i)(3): Eliminate from an individuals record any references to a temporary administrative withdrawal of Updated    authorization due to an initial positive marijuana and/or              28.0                1.0        28.0    0              1.0            -      (28.0) cocaine test result at an LTF that did not confirm positive after testing at an HHS lab 26.85(a) and (b): Training of urine and alcohol collectors and Updated                                                                          28.0                8.0       224.0      26.0         8.0       208.0      (16.0) maintain training records in personnel files 26.87(d)(3): If a collection site cannot be dedicated solely to collecting specimens, secure the portion of the facility when a Updated                                                                          28.0                1.0        28.0      26.0          1.0        26.0        (2.0) specimen collection is in process and post a sign indicating access permitted only to authorized personnel 26.87(f)(1) and (f)(3) - (f)(5): Post a sign outside the collection area (if a public restroom used) and document on the custody-and-control form (CCF) the name of a same Updated    gender observer (in the exceptional event that a designated            28.0                2.0        56.0        2.0          0.5          1.0      (55.0) collection site is inaccessible, the collector is not the same gender as the donor and a urine specimen must be immediately collected) 26.89(a): Collector notifies FFD management that a donor Updated                                                                          28.0                1.0        28.0       4.0        0.25          1.0     (27.0) failed to report to the collection site 26.89(b)(1), (b)(2), and (b)(4): Record that ID and consent-to-28.0               1.5        42.0      26.0         1.5        39.0       (3.0) testing form obtained 26.89(b)(3): Record that FFD management informed that an Updated                                                                          28.0               1.0       28.0       26.0         1.0         26.0       (2.0) individual did not present identification (pre-access testing) 26.89(c): Collector documents on CCF a donor's refusal to                                                  Burden accounted for under section Consolidated                                                                        28.0                1.0       28.0                                            (28.0) cooperate with the collection process                                                                                  26.107(b) 26.91(c)(1) - (c)(3): Record of evidential breath testing (EBT)     Burden accounted for under section    Burden accounted for under section Updated                                                                                                                                                            -
determine if positive, adulterated, substituted, or invalid 
device test results                                                            26.715(b)(2)                          26.715(b)(2) 26.91(e)(4): Record that results cancelled after EBT
 
                                                                                          -              6.0           -          0         6.0             -        -
result is scientifically insufficient for determination of FFD  
calibration check failure Updated   26.91(e)(5): EBT maintenance records                                  28.0               6.0      168.0       26.0         6.0        156.0      (12.0) 26.93(a)(6): Document that alcohol pre-test questions Updated                                                                          28.0              80.0   2,240.0       26.0         47.1      1,223.6    (1,016.4) communicated to the donor 26.95(b)(5): Record donor identity for initial alcohol breath 28.0              80.0    2,240.0       26.0         47.1      1,223.6   (1,016.4) test Updated    26.97(b)(2): Record reason for new oral fluid alcohol test                -              5.0           -          0        0.25             -        -
 
26.97(c)(1): Document reason for failure of 2nd collection Updated                                                                              -              2.5          -          0        0.25            -       -
policy violation                24.0                 1.0                 24.0 Consolidated in Table 2(24.0)
attempt 26.97(d): Record results and alcohol screening device used                -             0.25          -           0        0.25            -       -
Updated 26.185(n): Second HHS lab provides the MRO with test result report (for retesting of an aliquot of a single specimen
26.99(b): Record time of initial alcohol test of 0.02 percent or    Burden accounted for under section    Burden accounted for under section Updated                                                                                                                                                            -
 
higher blood alcohol concentration (BAC)                                        26.715(b)(2)                          26.715(b)(2)
or the testing of a Bottle B split specimen)                54.0                 1.0                 54.0                 31.1                0.25                7.8 (4 6.2)
Duplicative 26.101(b)(7): Record time and BAC result of confirmatory                                                    Burden accounted for under section
Duplicative Burden 26.185(o): HHS lab provides report with quantitative test results  for a specimen from a donor applying for reauthorization following a 1st positive drug test result (at
                                                                                          -                -          -                                             -
 
Burden    alcohol test                                                                                                          26.715(b)(2) 26.103(b): Record that FFD management notified of a Updated                                                                            8.0              0.25        2.0         8.0       0.25          2.0       -
MRO request)                  8.0                 0.5                  4.0 Duplicate with row below(4.0)
confirmatory alcohol test result of 0.01 to 0.02 percent BAC 26.107(b): Collector documents on CCF any donor conduct Updated    during collection process indicating an attempt to tamper with        28.0                0.1        2.8      26.0        0.25          6.5        3.7 a specimen, and notifies FFD management 26.109(b)(3): Collector documents on CCF that the donor Updated    was unable to provide a specimen in the 3-hour time allotted          28.0                0.5        14.0       26.0         0.25          6.5      (7.5)
Duplicative Burden 26.185(o): HHS lab provides quantitation of test results  for testing performed on a specimen from a donor applying for
(i.e., a shy bladder), and notifies FFD management Page 8 of 24
 
reauthorization following a 1st positive drug test result (at
 
MRO request)                   8.0                 1.0                   8.0 Burden accounted for under sections 26.169(c)(1)
(8.0)
Consolidated (in Table 2)26.185(p): MRO notice to licensee of determination of FFD policy violationBurden accounted for under section 26.185(c) Consolidated in Table 2 -
Consolidated (in Table 2) 26.187(d): SAE training requirements                24.0                20.0               480.0 Consolidated in Table 2(480.0)
Consolidated (in Table 2) 26.187(f): Documentation of SAE credentials and training                24.0                 1.0                 24.0 Consolidated in Table 2(24.0)
Updated 26.189(b): If a qualified treatment professional other than the MRO or SAE performs a determination of fitness on an  
 
individual, that treatment professional completes and
 
provides a written determination to the MRO                69.0                 1.0                 69.0 26.0                               1.0               26.0 (43.0)
Consolidated (in Table 2) 26.189(c): Written record of a For-cause determination of fitness                  6.9                  1.0                   6.9  Consolidated in Table 2 (6.90)
Consolidated (in Table 2) 26.189(d): Modification of an initial determination of fitness based on information from other sources                24.0                 1.0                 24.0 Consolidated in Table 2 (24.0)
Updated 26.209(a): Individual declares that due to fatigue, he or she is unable to safety and competently perform his or her
 
duties                23.0                 0.3                  6.9                21.0                 0.3                6.3 (0.60)
Removed 26.405(g): For a reactor construction site FFD program, MRO reports of positive, adulterated, substituted, or invalid
 
drug test results (for a reactor construction site FFD D&A
 
testing program)                90.0                 1.0                 90.0 Removed (This is not third-party burden)
(90.0)
Updated 26.411(b): Applicant provides written consent to the reactor construction site D&A testing program            4,675.0                 0.3            1,402.5            6,898.0               0.25         1,724.5 322.00 NEW 26.715(a): Documentation of all aspects of HHS lab testing process, not specified elsewhere in section 26.715(b)
Previously accounted for in Table 2 as Annualized Burden Burden covered by HHS lab certification requirements OMB Clearance No. 0930-0158
-
Page 20 of 24 FINAL Supporting Statement, 10 CFR Part 26 Index Key:- Consolidated- Duplicative
- Moved
- New
- Removed
- Updated Section Number of Responses Burden Hours per Response Total Annual Burden Hours Number of Responses Burden Hours per Response Total Annual Burden Hours Approved Clearance Values (approved 11/30/14 - ICR 201407-3150-007)
Extension (2017-2020)
Table 4: Annual Third-Party Disclosure Burden Estimate Change NEW 26.715(b)(1): Retain personnel files on HHS lab staff Previously accounted for in Table 2 as Annualized Burden Burden covered by HHS lab certification requirements OMB Clearance No. 0930-0158
-
NEW 26.715(b)(2): Retain HHS lab chain-of-custody documents Previously accounted for in Table 2 as Annualized Burden                  9.0             240.0         2,160.0 2,160.00 NEW 26.715(b)(3): Retain HHS lab QA/QC records Previously accounted for in Table 2 as Annualized Burden Burden covered by HHS lab certification requirements OMB Clearance No. 0930-0158
-
NEW 26.715(b)(4): Retain HHS lab superseded procedures Previously accounted for in Table 2 as Annualized Burden                  9.0                40.0             360.0 360.00 NEW 26.715(b)(5) Retain all test data from HHS lab (including calibration curves and any calculations used in determining


test results)
Final Supporting Statement, 10 CFR Part 26 Approved Clearance Values                          Extension Table 2: Annual Recordkeeping                                                  (approved 11/30/14 - ICR 201407-3150-                  (2017-2020)
Previously accounted for in Table 2 as Annualized Burden Burden covered by HHS lab certification requirements OMB Clearance No. 0930-0158
Index Key:
-
Burden
NEW 26.715(b)(6): HHS lab test reports Previously accounted for in Table 2 as Annualized Burden                  9.0           240.00          2,160.0 2,160.00 NEW 26.715(b)(7): HHS lab performance testing records Previously accounted for in Table 2 as Annualized Burden Burden covered by HHS lab certification requirements OMB Clearance No. 0930-0158
- New                                                                                                            Total                  Burden        Total Number of        Burden                    Number of                              Estimate
-
- Updated                                                                                                      Annual                  Hours per      Annual Section                                                          Record-      Hours per                    Record-                              Change
Updated 26.719(c): HHS lab provides information to the licensee or other entity on investigation completed on a testing error (information for 30-day event report to NRC)                   6.0                 8.0                 48.0                   8.0                 8.0              64.0 16.00 26.821(b): Written agreement between C/Vs and licensees to permit authorized NRC representatives to inspect, copy, or take away copies of C/V's documents, records, and
- Moved                                                                                                        Burden                  Record-      Burden keepers    Recordkeeper                    keepers
- Duplicative                                                                                                  Hours                    keeper        Hours
- Removed 26.109(b)(4): Collector documents on CCF if a specimen (less than 30 mL) appears to be tampered with and/or donor                                                  Burden accounted for under section Consolidated                                                                      28.0                0.3          8.4                                              (8.4) behavior during collection indicated a possible subversion                                                              26.107(b) attempt, and notifies FFD management 26.111(b): Collector documents on CCF if specimen Burden accounted for under section Consolidated characteristics (color, clarity) indicate possible tampering by        4.0                0.3          1.0                                              (1.0) 26.107(b) the donor 26.111(c): Collector documents on CCF unusual specimen Burden accounted for under section Consolidated temperature and/or observations during the collection                28.0                0.3          8.4                                              (8.4) 26.107(b) indicating possible tampering, and notifies FFD management.
26.113(b)(3): Collector completes CCF for split-specimen                                                        Burden accounted for under Updated                                                                        28.0                0.3          8.4                                              (8.4) collection                                                                                                        section 26.117(c) - (e) 26.115(b): Collector documents on CCF approval from FFD Updated    manager or MRO to collect a specimen under direct                    28.0                0.5        14.0        26.0          0.5          13.0      (1.0) observation Duplicative 26.115(d): Collector documents on CCF that observed                                                            Burden accounted for under 28.0                0.3          8.4                                              (8.4)
Burden    collection performed and reason for the observed collection                                                          section 26.115(b)
Duplicative 26.115(f)(3): Collector documents on CCF the name of                                                            Burden accounted for under 28.0                0.3          8.4                                              (8.4)
Burden    observer of directly observed collection                                                                            section 26.115(b) 26.117(c) - (e): Collector prepares ID labels and CCF forms Updated                                                                        28.0                60.0      1,680.0        26.0        188.2        4,894.4    3,214.4 for specimen shipment 26.119(a), (e), and (f): Written evaluation from the physician who performed a medical evaluation of a donor with a shy Updated                                                                        28.0                6.0        168.0        13.0          2.0          26.0    (142.0) bladder (i.e., unable to provide a specimen of adequate volume in the allotted 3-hours) 26.119(b): Record that MRO provided information and Updated    instructions to the physician who is to perform the                  28.0                2.0         56.0        13.0          1.0          13.0      (43.0) examination of a donor with a shy bladder 26.125(b) and (c): Records on the proficiency and Updated                                                                          7.0              16.0        112.0          6.0        16.0          96.0      (16.0) qualifications of LTF personnel 26.127 (a) - (e): Maintain LTF written procedures on the handling of specimens, chain-of-custody procedures, testing Updated                                                                          7.0            200.0      1,400.0          6.0        40.0          240.0  (1,160.0) assays, instrument and device setup, and remedial actions for systems and testing devices.
26.129(a): Maintain documentation of access to secure areas Updated                                                                          7.0                2.5        17.5          6.0        4.0          24.0        6.5 of an LTF by all authorized individuals (i.e., an access log) 26.129(b): LTF inspects specimen packages, CCFs, and Updated    obtains memorandum from specimen collectors to correct                7.0                0.5          3.5        6.0        0.5            3.0      (0.5) identified discrepancies 26.129(b)(1): LTF record of report to senior licensee or other Updated    entity management of attempts to tamper with specimens in              7.0                1.0          7.0          0        1.0              -      (7.0) transit 26.129(d): LTF procedures for tracking CCF of specimens                7.0              80.0        560.0          6.0        80.0          480.0      (80.0) 26.135(b): LTF record of direction from MRO to send Bottle Updated                                                                          7.0                2.2        15.4          6.0        0.5            3.0      (12.4)
B of a split specimen to a second HHS lab for testing 26.137(a): Record of a QA/QC program and procedures for 7.0                4.0        28.0          6.0        4.0          24.0      (4.0)
LTF 26.137(b)(1)(ii): LTF documentation of performance testing Updated    of a device not approved by SAMHSA for point-of-collection            2.0              40.0        80.0            0        40.0              -      (80.0) testing 26.137(b)(1)(iii): LTF documentation of annual test results for Updated    a device not approved by SAMHSA for point-of-collection                2.0              20.0        40.0            0        20.0              -     (40.0) testing 26.137(b)(3): LTF records submitting 1 in 10 specimens that Updated    test negative on validity screening testing are sent to an HHS         7.0              40.0        280.0            0        40.0              -    (280.0) lab as part of the LTF's QA program 26.137(d)(6): LTF records that 1 in 10 specimens that test NEW      negative on initial validity testing are sent to an HHS lab for          Not included in clearance                  6.0        40.0          240.0      240.0 testing as part of the LTFs QA program Duplicative 26.137(e)(7): LTF documented procedures to protect against                                                      Burden accounted for under 7.0                2.0        14.0                                              (14.0)
Burden    carryover material                                                                                                section 26.127 (a) - (e)
Updated    26.137(f)(5): LTF records on testing errors                            7.0              24.0        168.0          6.0         8.0           48.0     (120.0)
Updated    26.137(h): LTF labeling of standards and controls                      7.0              65.0       455.0          6.0        40.0          240.0    (215.0) 26.139(d): Record that the LTF prepared a summary of test Updated    results for inclusion in the FFD annual program performance            7.0              40.0        280.0          6.0        40.0          240.0      (40.0) report submitted under section 26.717 Moved    26.153(e): Record of pre-award inspection of new HHS lab 28.0              40.0      1,120.0          Moved to Table 1                (1,120.0)
(to Table 1) (completed prior to awarding contract for testing services)
Moved    26.153(f): Records that Part 26 specified requirements 28.0              40.0      1,120.0          Moved to Table 1                (1,120.0)
(to Table 1) included in contract with HHS lab Page 9 of 24


reports                   5.0                 4.0                 20.0                   5.0                 4.0               20.0  
Final Supporting Statement, 10 CFR Part 26 Approved Clearance Values                        Extension Table 2: Annual Recordkeeping                                                      (approved 11/30/14 - ICR 201407-3150-                (2017-2020)
-
Index Key:
Table 4 Total        410,999.9       303,559.1        441,569.1      492,029.4        188,470.3 62.1%Page 21 of 24 FINAL Supporting Statement, 10 CFR Part 26 Index Key:- Updated- Consolidated
Burden
- Removed NRC ACTION No. Actions/
- New                                                                                                              Total                  Burden        Total Number of        Burden                    Number of                              Estimate
Year Burden Hours / Action Total Hours No. Actions/
- Updated                                                                                                          Annual                  Hours per      Annual Section                                                            Record-      Hours per                    Record-                              Change
Year Burden Hours / Action Total Hours Updated Review exemption request under section 26.9                    2.0             16.0             32.0                   -              16.0             -  (32.0)
- Moved                                                                                                            Burden                   Record-      Burden keepers    Recordkeeper                    keepers
Updated Review FFD policies and procedures under section 26.27(d) (performed during periodic inspections)                 12.0                8.0             96.0                12.0             8.0         96.0 -
- Duplicative                                                                                                      Hours                    keeper        Hours
Updated Review records under section 26.75(h) to ensure only appropriate records maintained for a licensee or other entity
- Removed 26.153(g): Record of memorandum sent to the HHS lab Updated                                                                            28.0                0.5          14.0      26.0          0.5           13.0      (1.0) explaining use of non-federal CCF form 26.159(b)(1): Record that the licensee or other entity Updated    received noticed from an HHS lab within 24 hours of the lab            28.0                1.0          28.0    0              1.0             -      (28.0) identifying evidence of tampering with specimen.
26.159(i): Record of written authorization to store specimens 28.0                0.5          14.0       26.0         0.5           13.0      (1.0) other than 1 year Duplicative 26.163(a)(2): Record that special analyses testing conducted                                                  Burden accounted for under section 28.0                1.0          28.0                                             (28.0)
Burden    on a dilute specimen and report of the test results                                                                      26.169(c)(1) 26.165(b)(1): Record of a donor request for the retesting of Duplicative                                                                                                                Burden accounted for under section an aliquot of a single specimen or the testing of the Bottle B          28.0                1.0          28.0                                            (28.0)
Burden                                                                                                                              26.165(b)(6) split specimen at a second HHS lab 26.165(b)(2): Record that MRO informed the donor of the Duplicative opportunity to request the retesting of an aliquot of a single                                                Burden accounted for under section 28.0                0.5          14.0                                             (14.0)
Burden    specimen or the testing of the Bottle B split specimen at a                                                                26.185(c) second HHS lab 26.165(b)(3): Donor's written permission provided to the MRO for the retesting of an aliquot of a single specimen or          Burden accounted for under section        Burden accounted for under section Updated                                                                                                                                                                -
the testing of the Bottle B split specimen at a second HHS                      26.165(b)(1)                            26.165(b)(6) lab 26.165(b)(4): Record that the donor presented Duplicative                                                                                                                Burden accounted for under section documentation to the MRO on the inability to submit a timely            6.0                0.2          1.2                                              (1.2)
Burden                                                                                                                                26.185(c) request to initiate specimen retesting at a second HHS lab 26.165(b)(6): MRO reviews HHS lab results on the retesting of an aliquot of a single specimen or testing of the Bottle B Updated                                                                            28.0                3.0          84.0      26.0          1.2          31.1      (53.0) split specimen, informs the donor of the results, and notified FFD management 26.165(c)(4): Results report received from the second HHS Burden accounted for under Updated    lab that performed retesting an aliquot of a single specimen            12.0                2.5          30.0                                            (30.0) section 26.165(b)(6) or the testing of the Bottle B split specimen 26.165(f)(1): Adjustments to personnel files and written notifications regarding the results of retesting an aliquot of a Updated                                                                            28.0                6.0       168.0      0              6.0              -    (168.0) single specimen or testing of the Bottle B split specimen, including temporary administrative action 26.165(f)(1)(iv) and (f)(2): Written record and notice that Updated    records purged of references to temporary administrative                28.0                8.0       224.0      0              8.0              -    (224.0) action 26.167(f)(3): Record received from the Responsible Person of an HHS lab on a false positive BPTS testing error (determined to be technical or methodological),
Updated    demonstrating that retesting of all positive, adulterated,              12.0                1.0          12.0    0              1.0              -     (12.0) substituted, and invalid specimens from the time of final resolution of the error back to the time of the last satisfactory performance test cycle has been completed 26.168(a) Maintain documentation of HHS lab certification of NEW                                                                                  Not included in clearance                26.0          2.6          67.0      67.0 BPTS formulation 26.168(i)(2): Licensee or other entity completes CCF for a Moved    BPTS, places fictional initials on specimen labels, and Moved from Table 4                   26.0         34.4          893.3     893.3 (from Table 4) indicates on the MRO copy of the CCF that the specimen is a BPTS 26.169(a): Records of reports of test results from the HHS                  Burden covered under                Burden accounted for under Updated                                                                                                                                                               -
lab                                                                  section 26.169(c)(1) through (c)(5)            section 26.183(c)(1) 26.169(c)(1): Records of HHS lab reports of positive, Duplicative                                                                                                                  Burden accounted for under adulterated, substituted, dilute, and invalid test results              12.0              80.0        960.0                                            (960.0)
Burden                                                                                                                         section 26.183(c)(1) received by the MRO 26.169(c)(2): Records of HHS lab reports of the numerical Duplicative                                                                                                                  Burden accounted for under values of all positive drug test results (i.e., quantitative test      12.0                1.0          12.0                                            (12.0)
Burden                                                                                                                         section 26.183(c)(1) results requested by MRO)
Duplicative 26.169(c)(2): Records of HHS lab reports of quantitative test                                                    Burden accounted for under 12.0               0.5          6.0                                              (6.0)
Burden    results for opiates                                                                                                  section 26.183(c)(1)
Duplicative 26.169(c)(3): Records of HHS lab reports of quantitative test                                                    Burden accounted for under 12.0               2.5          30.0                                             (30.0)
Burden    results for adulterated or substituted test results                                                                  section 26.183(c)(1) 26.169(c)(4): Record of MRO contact with HHS lab to Duplicative                                                                                                                  Burden accounted for under discuss whether testing by another HHS lab should be                    12.0                2.0          24.0                                            (24.0)
Burden                                                                                                                          section 26.185(f)(1) conducted on a specimen with an invalid result Duplicative                                                                                                                  Burden accounted for under 2.0                1.0           2.0                                             (2.0)
Burden                                                                                                                          section 26.183(c)(1) 26.169(f): Records of HHS lab transmittals of CCF copies for Updated                                                                           12.0              109.5      1,314.0        26.0        47.1        1,223.6      (90.4) negative results to the MRO Page 10 of 24


who administratively withdraws access for initial positive drug  
Final Supporting Statement, 10 CFR Part 26 Approved Clearance Values                        Extension Table 2: Annual Recordkeeping                                                      (approved 11/30/14 - ICR 201407-3150-                (2017-2020)
Index Key:
Burden
- New                                                                                                            Total                    Burden        Total Number of      Burden                    Number of                                Estimate
- Updated                                                                                                      Annual                  Hours per      Annual Section                                                            Record-      Hours per                  Record-                                Change
- Moved                                                                                                        Burden                    Record-      Burden keepers    Recordkeeper                  keepers
- Duplicative                                                                                                    Hours                    keeper        Hours
- Removed 26.169(g): HHS lab copy of the original CCF for each Duplicative                                                                                                                  Burden accounted for under positive, adulterated, substituted, dilute, and invalid test            12.0              44.7      536.4                                              (536.4)
Burden                                                                                                                          section 26.169(c)(1) results to the MRO 26.169(h): Record of HHS lab statistical summary report of Updated                                                                            12.0              40.0      480.0          26.0        2.0            52.0    (428.0) urinalysis testing results (for the calendar year)
Updated    26.183(a): Documentation of MRO qualifications                          28.0                3.5      98.0          26.0        4.0          104.0        6.0 26.183(c)(1): MRO review of HHS lab test result record for Updated    positive, adulterated, substituted, invalid, or at the licensee's      28.0              19.1      534.8          26.0        2.0            51.8    (483.1) or other entity's discretion, dilute specimen 26.183(d)(1)(ii)(D): Record of MRO report of confirmed drug Updated    positive, adulterated, substituted, or refusal to test result to        28.0              19.1      534.8          26.0        2.0            51.8    (483.1) the licensees designated reviewing official 26.183(d)(2)(i): Record of MRO staff review and reporting of Updated                                                                            28.0            292.2    8,181.6          26.0      282.4        7,341.5      (840.1) negative test results to FFD management 26.183(d)(2)(ii): Record of MRO staff review of CCFs for Updated    positive, adulterated, substituted and invalid results and              28.0                1.9      53.2          26.0        2.4            62.1        8.9 forwards changes to MRO for review 26.185(a) Record of MRO review of a drug positive,                                                                Burden accounted for under Updated                                                                            28.0              26.0      728.0                                              (728.0) adulterated, substituted, dilute, or invalid HHS lab test result                                                    section 26.183(c)(1) 26.185(c): Record of MRO discussion of positive, Updated    adulterated, substituted, dilute, or invalid test result with          28.0              26.0      728.0          26.0        11.9          310.5      (417.5) donor Duplicative 26.185(d)(1): Documentation that donor declined to discuss                                                  Burden accounted for under section 28.0                2.0      56.0                                                (56.0)
Burden    test results with MRO                                                                                                      26.185(c) 26.185(e): Documentation reviewed by the MRO on a donors Updated    inability to discuss test results and a request to reopen              28.0                0.3        8.4        26.0        0.5            13.0        4.6 proceeding 26.185(f)(1): Record of MRO consultation with HHS lab to Updated    determine whether additional testing needed for an invalid              28.0                0.5      14.0          26.0        0.5            13.0      (1.0) specimen Duplicative 26.185(f)(2): Record of MRO contact with donor about an                                                          Burden accounted for under 28.0                0.5      14.0                                                (14.0)
Burden    invalid test result, and medical information received                                                                section 26.185(c)
Duplicative 26.185(h)(1): Record of MRO contact with donor about a                                                            Burden accounted for under 28.0                2.0      56.0                                                (56.0)
Burden    substituted test result, and medical information received                                                            section 26.185(c)
Duplicative 26.185(h)(2): Record of MRO confirmation of a substituted                                                        Burden accounted for under 28.0                2.0      56.0                                                (56.0)
Burden    test result (no legitimate medical explanation)                                                                  section 26.183(d)(1)(ii)(D)
Duplicative 26.185(h)(3): MRO record of determination of a legitimate                                                        Burden accounted for under 28.0                1.0      28.0                                                (28.0)
Burden    medical explanation for a substituted test result                                                                  section 26.183(d)(2)(i)
Duplicative 26.185(i)(1): Record of MRO contact with donor about an                                                          Burden accounted for under 28.0                2.0      56.0                                                (56.0)
Burden    adulterated test result, and medical information received                                                            section 26.185(c)
Duplicative 26.185(i)(2): Record of MRO confirmation of an adulterated                                                        Burden accounted for under 28.0                2.0      56.0                                                (56.0)
Burden    test result (no legitimate medical explanation)                                                                  section 26.183(d)(1)(ii)(D)
Duplicative 26.185(i)(3): MRO record of determination of a legitimate                                                        Burden accounted for under 28.0                1.0      28.0                                                (28.0)
Burden    medical explanation for an adulterated test result                                                                  section 26.183(d)(2)(i) 26.185(j): Prescription medication drug positives (applies to amphetamine, morphine, and codeine results) - records of Updated                                                                            28.0                1.5      42.0          26.0        2.3            60.0      18.0 MRO review of HHS lab result, discussion of positive result with donor, and review medication information from the donor 26.185(k): Record of MRO report to licensee that no FFD policy violation has occurred (i.e., legitimate prescription medication used in a manner and at the dosage prescribed).                                                        Burden accounted for under Duplicative If the individual poses a potential risk to public health and          28.0                1.0      28.0  sections 26.183(d)(2)(i) and 26.185(c)        (28.0)
Burden safety because of impairment while on duty - the MRO will ensure that a determination of fitness is performed) 26.185(m): Record of MRO review of inspection and audit reports, QC data, multiple specimens, and other data to determine if positive, adulterated, substituted, or invalid result      28.0                1.0      28.0          26.0        1.0            26.0      (2.0) is scientifically insufficient for determination of FFD policy violation 26.185(n): Record of MRO review of a positive, adulterated or substituted test result from a second HHS lab (results of Updated    retesting a single specimen or testing of a Bottle B split              28.0                2.0      56.0          26.0        0.60            15.5      (40.5) specimen), and MRO communication of the test result to the donor, and report results to FFD management 26.185(o): Record of MRO request and HHS lab report of quantitation test results for testing performed on a specimen Updated                                                                            28.0                1.5      42.0          26.0        0.50            13.0      (29.0) from a donor applying for reauthorization following a 1st positive drug test result Duplicative 26.185(p): MRO written notice to licensee or other entity of a                                                    Burden accounted for under 28.0                8.0      224.0                                              (224.0)
Burden    positive, adulterated, substituted, or invalid test result                                                            section 26.185(c)
Page 11 of 24


tests for marijuana or cocaine at an LTF (performed during
Final Supporting Statement, 10 CFR Part 26 Approved Clearance Values                        Extension Table 2: Annual Recordkeeping                                                    (approved 11/30/14 - ICR 201407-3150-                (2017-2020)
Index Key:
Burden
- New                                                                                                          Total                    Burden          Total Number of      Burden                    Number of                                Estimate
- Updated                                                                                                      Annual                  Hours per      Annual Section                                                            Record-      Hours per                  Record-                                Change
- Moved                                                                                                        Burden                    Record-      Burden keepers    Recordkeeper                  keepers
- Duplicative                                                                                                  Hours                    keeper        Hours
- Removed 26.713(a)(2): Records pertaining to the determination of a                                                    Burden accounted for under Consolidated                                                                        28.0              80.0    2,240.0                                            (2,240.0) violation of FFD policy and related management actions                                                              section 26.39(b) 26.713(a)(3): Documentation of the granting and termination Updated                                                                          28.0              80.0    2,240.0        26.0        80.0        2,080.0      (160.0) of authorization 26.713(a)(4): Records of determinations of fitness Updated    performed under section 26.189 (including recommendations              28.0              80.0    2,240.0        26.0        80.0        2,080.0      (160.0) for treatment and followup testing plans)
Duplicative 26.713(b)(1): Records of FFD training and examinations                                                        Burden accounted for under 28.0            160.0    4,480.0                                            (4,480.0)
Burden    conducted under section 26.29                                                                                  sections 26.29(a) and (b)
Duplicative 26.713(b)(2): Records of audits, audit findings, and corrective                                                Burden accounted for under 28.0              80.0    2,240.0                                            (2,240.0)
Burden    actions taken under section 26.41                                                                            sections 26.41(a)-(d), (f) and (g) 26.713(c): Records on 5-year and permanent denials of                                                          Burden accounted for under Consolidated                                                                        28.0              40.0    1,120.0                                            (1,120.0) authorization                                                                                                        section 26.39(b) 26.713(d): Records of superseded versions of FFD policies Updated                                                                          28.0              80.0    2,240.0        26.0          8.0          208.0    (2,032.0) and procedures 26.713(e): Records of written agreements for services under Updated                                                                          28.0              16.0      448.0        26.0        16.0          416.0      (32.0)
Part 26 26.713(f): Records of background investigations, credit and Duplicative criminal history checks, and psychological assessments of                                                      Burden accounted for under 28.0              80.0    2,240.0                                            (2,240.0)
Burden    FFD program personnel conducted under section                                                                      section 26.31(b)(1)(i) 26.31(b)(1)(i) 26.713(g): Documentation on testing for additional drugs as Moved    permitted under section 26.31(d)(1), use of more stringent 28.0              40.0    1,120.0            Moved to Table 1                (1,120.0)
(to Table 1) testing cutoff levels as permitted under section 26.31(d)(3),
or both 26.715(a): Documentation of all aspect of testing process at Updated    collection sites and LTFs (not otherwise specified in section          28.0              40.0    1,120.0        26.0        40.0        1,040.0      (80.0) 26.715(b))
26.715(b)(1): Retain personnel files on staff at collection sites Updated                                                                          28.0              20.0      560.0        26.0        20.0          520.0      (40.0) and LTFs 26.715(b)(2): Retain collection site and LTF chain-of-custody Updated                                                                          28.0            240.0    6,720.0        26.0      240.0        6,240.0      (480.0) documents Updated    26.715(b)(3): Retain LTF QA/QA records                                28.0            120.0    3,360.0          6.0      120.0          720.0    (2,640.0) 26.715(b)(4): Retain superseded procedures (LTFs and Updated                                                                          28.0              40.0    1,120.0        26.0        40.0        1,040.0      (80.0) collection sites) 26.715(b)(5): Retain all test data from LTF (including Updated    calibration curves and any calculations used in determining            28.0            240.0    6,720.0          6.0      240.0        1,440.0    (5,280.0) test results Updated    26.715(b)(6): LTF test reports                                        28.0            240.0    6,720.0          6.0      240.0        1,440.0    (5,280.0)
Updated    26.715(b)(7): LTF performance testing records                          28.0              80.0    2,240.0          6.0        80.0          480.0    (1,760.0) 26.715(b)(8): Records from LTF and HHS lab on the Updated    investigation of testing errors or unsatisfactory performance,        28.0              40.0    1,120.0          8.0        40.0          320.0      (800.0) and any corrective actions taken Moved    26.715(b)(9): Performance records on HHS lab certification 28.0              40.0    1,120.0            Moved to Table 4                (1,120.0)
(to Table 4) inspections 26.715(b)(10): Records of preventative maintenance on LTF Updated                                                                          28.0              40.0    1,120.0          6.0        40.0          240.0      (880.0) instruments 26.715(b)(11): Retain records that summarize any test Updated    results the MRO determined to be scientifically insufficient for      28.0              20.0      560.0          1.0          3.0            3.0    (557.0) further action Updated    26.715(b)(12): LTF retains computer-generated data                    28.0            120.0    3,360.0          6.0      120.0          720.0    (2,640.0) 26.715(b)(13): Retain records (e.g., an access log) of Duplicative                                                                                                            Burden accounted for under section authorized visitors, maintenance personnel and service                28.0              20.0      560.0                                              (560.0)
Burden                                                                                                                            26.129(a) personnel who accessed LTF secure areas 26.715(b)(14): Retain records of the inspection, maintenance Updated                                                                          28.0              20.0      560.0        26.0        20.0          520.0      (40.0) and calibration of EBTs (collection sites) 26.717(a) and (b): Collect FFD performance data for D&A 28.0            100.0    2,800.0        26.0      100.0        2,600.0      (200.0) testing programs 26.717(a) and (b): Collect FFD performance data for fatigue 23.0            100.0    2,300.0        21.0      100.0        2,100.0      (200.0) management program 26.717(c): Analyze D&A testing program FFD data annually              28.0              40.0    1,120.0        26.0        40.0        1,040.0      (80.0) 26.717(c): Analyze fatigue management program data 23.0              40.0      920.0        21.0        40.0          840.0      (80.0) annually 26.717(d): D&A test results leading to termination                      1.0              1.0        1.0        1.0          1.0            1.0        -
Duplicative 26.717(g): Collect and report D&A testing program data to                                                      Burden accounted for under 1.0            120.0      120.0                                              (120.0)
Burden    the NRC (for C/V with a testing program)                                                                        section 26.717(a) and (b) 26.719(b): Prepare information to make a 24-hour event Updated                                                                            1.2              1.0        1.2        37.0        1.0            37.0      35.8 report to the NRC Updated    26.719 (c): Prepare 30-day event report documentation.                  0.2              40.0        8.0          8.0        40.0          320.0      312.0 26.719(d): Document non-reportable indicators of FFD 30.0              20.0      600.0        28.0        20.0          560.0      (40.0) program weaknesses Page 13 of 24


periodic inspections)                 12.0                4.0              48.0                   -                4.0             -   (48.0)
Final Supporting Statement, 10 CFR Part 26 Approved Clearance Values                            Extension Table 2: Annual Recordkeeping                                                    (approved 11/30/14 - ICR 201407-3150-                    (2017-2020)
Updated Review and evaluate report made under section 26.77(c) regarding an NRC employee or contractor being unfit for duty
Index Key:
                      -
Burden
No reports anticipated                  -                      -               4.0            -  -
- New                                                                                                              Total                    Burden        Total Number of        Burden                      Number of                              Estimate
Updated Review documentation provided by SAE upon request by NRC under section 26.187(f)                   1.0                4.0                4.0                 1.0             4.0          4.0 -
- Updated                                                                                                          Annual                  Hours per      Annual Section                                                          Record-      Hours per                      Record-                                Change
Consolidated Review and evaluate a 24-hour report made under section 26.417(b)(1) to the NRC Operations Center regarding a
- Moved                                                                                                            Burden                    Record-      Burden keepers    Recordkeeper                    keepers
- Duplicative                                                                                                      Hours                    keeper        Hours
- Removed 26.187(d): SAE training requirements                                  28.0                20.0          560.0        26.0        20.0          520.0      (40.0) 26.187(f): Documentation of SAE credentials and training              28.0                1.0          28.0        26.0          1.0          26.0      (2.0)
Updated    26.189(b): Determination of fitness record                            28.0                80.2        2,245.6        26.0        80.0        2,080.0    (165.6)
Updated    26.189(c): Record of for cause determination of fitness              28.0                16.3          456.4       26.0        15.6          405.3      (51.1) 26.189(d): Record of modification of an initial determination Updated                                                                          28.0                1.0          28.0        1.0          1.0            1.0      (27.0) of fitness 26.203(a): Prepare fatigue management policy (In addition to 2.0                7.3          14.6            0        7.3             -      (14.6) 26.27 burden) 26.203(b): Prepare fatigue management procedures (in 2.0               1.7            3.4            0        1.7              -       (3.4) addition to 26.27 burden) 26.203(c): Prepare training on fatigue management.                      2.0               2.0            4.0           0        2.0              -       (4.0) 26.203(d)(1) and (d)(2): Records of work hours, shift                  Burden accounted for under                Burden accounted for under Updated                                                                                                                                                                -
schedules, and shift cycles                                            26.205(c), (d)(1), and (e)(4)            26.205(c), (d)(1), and (e)(4)
Burden accounted for under                Burden accounted for under 26.203(d)(3): Documentation of waivers                                                                                                                      -
section 26.207(a)(4)                      section 26.207(a)(4)
Burden accounted for under                Burden accounted for under 26.203(d)(4): Documentation of work hour reviews                                                                                                            -
26.205(d)(2), (e)(3) and (e)(4)          26.205(d)(2), (e)(3) and (e)(4)
Burden accounted for under                Burden accounted for under 26.203(d)(5): Documentation of fatigue assessment                                                                                                            -
section 26.211(f)                          section 26.211(f) 26.205(b): Record of calculation of work hours                        23.0              160.0        3,680.0        21.0        160.0        3,360.0    (320.0) 26.205(c): Schedule work hours                                        23.0            2,080.0      47,840.0        21.0      2,080.0      43,680.0  (4,160.0) 26.205(d)(1): Record of implementation of work hour 23.0                50.0        1,150.0        21.0        50.0        1,050.0    (100.0) controls 26.205(d)(2): Record of adequate rest breaks                          23.0                50.0        1,150.0        21.0        50.0        1,050.0    (100.0) 26.205(e)(1) and (2): Record of review of control of work 23.0                40.0          920.0        21.0        40.0          840.0      (80.0) hours twice per calendar year 26.205(e)(3): Document methods for reviews                            23.0                20.0          460.0        21.0        20.0          420.0      (40.0) 26.205(e)(4): Record and trend problems in regarding work 23.0               20.0          460.0        21.0        20.0          420.0      (40.0) hours Updated    26.207(a)(4): Document basis for waiver                                3.0                6.0          18.0        21.0          6.0          126.0      108.0 26.211(f): Document results of fatigue assessments                    23.0                50.0        1,150.0        21.0        50.0        1,050.0    (100.0) 26.403(a): Updates to FFD policy and procedures NEW                                                                                Not included in clearance                  2.0        16.0          32.0      32.0 (reactor construction site D&A testing program)
Moved    26.403(a): Provide FFD policy to individuals subject to a Moved from Table 1                        2.0          8.0          16.0      16.0 (from Table 1) reactor construction site D&A testing program Updated    26.405(b): Records of random D&A tests                                  2.0            705.0        1,410.0          2.0      193.9          387.7  (1,022.3)
Updated    26.405(c)(1): Records of pre-assignment D&A test                        2.0          2,338.0        4,676.0          2.0      287.4          574.8   (4,101.2) 26.405(c)(2) and (c)(3): Records of for-cause and post Updated                                                                            2.0            197.0          394.0          2.0      308.8          617.7      223.7 accident D&A tests Updated    26.405(c)(4): Records of follow-up D&A tests                            2.0              34.5          69.0          2.0        21.1          42.1      (26.9)
Moved    26.405(d): Record of testing for specified drugs, adulterants,          Burden accounted for under Moved to Table 1                    -
(to Table 1) and alcohol, at Part 26 specified cutoff levels                          section 26.405(a) - (c)(4) 26.405(e): Updates to specimen collection and D&A testing procedures to protect the donor's privacy, integrity of the Updated                                                                            2.0              40.0          80.0          2.0        40.0          80.0        -
specimen, and stringent quality controls to ensure accurate test results 26.405(f): Record that testing conducted at an HHS lab                  2.0              40.0          80.0          2.0        40.0          80.0        -
26.405(g): Record of MRO review of positive, adulterated, Updated    substituted, and invalid drug and validity test results (reactor        2.0              50.0          100.0          2.0        81.3          162.5      62.5 construction site D&A testing program) 26.406(c): Updates to fitness monitoring procedures Updated    (programs that do not adopt random testing and behavioral                -              80.0              -            0        80.0             -        -
observation) 26.411(a): Updates to procedures for maintaining a system Updated    of files to protect personal information collected under               2.0                4.0           8.0          2.0        40.0          80.0      72.0 Subpart K of Part 26 26.411(a) and (b): Collection of personal information under Updated    Subpart K of Part 26                                                    2.0          2,190.5        4,381.0          2.0     3,817.0        7,634.0    3,253.0 26.413: Document results of review process                              2.0              80.0          160.0          2.0        80.0          160.0        -
26.415: Document and report audit results                              2.0              40.0          80.0          2.0        40.0          80.0        -
26.417(a): Records pertaining to the administration of a Updated                                                                            2.0              20.0          40.0          2.0        20.0          40.0        -
reactor construction site D&A testing program 26.417(b)(1): Report to NRC by telephone within 24 hours Burden accounted for under NEW      programmatic failures in a reactor construction site D&A                  Not included in clearance section 26.719(b) testing program 26.417(b)(2) Collect FFD program performance data for Updated                                                                            2.0            100.0          200.0          2.0      100.0          200.0        -
reactor construction site D&A testing program 26.713(a)(1): Records of self-disclosures, employment Duplicative                                                                                                                Burden accounted for under section histories, and suitable inquiries (under sections 26.55, 26.57,      28.0                80.0        2,240.0                                          (2,240.0)
Burden                                                                                                                  26.61(a), and 26.63(a), (c), and (e) 26.59, and 26.69) that result in the granting of authorization Page 12 of 24


significant FFD program failure                   1.0             16.0             16.0 Burden accounted for under section 26.719(b)
Final Supporting Statement, 10 CFR Part 26 Approved Clearance Values                        Extension Table 2: Annual Recordkeeping                                              (approved 11/30/14 - ICR 201407-3150-                (2017-2020)
(16.0)
Index Key:
Updated Annual FFD program performance report -
Burden
Review, analyze, and summarize information received under
- New                                                                                                    Total                  Burden    Total Number of      Burden                    Number of                          Estimate
- Updated                                                                                              Annual                  Hours per  Annual Section                                                      Record-      Hours per                   Record-                          Change
- Moved                                                                                                Burden                    Record-  Burden keepers    Recordkeeper                  keepers
- Duplicative                                                                                            Hours                    keeper    Hours
- Removed 26.821(a): Provide NRC with access to records (to inspect, Updated                                                                    30.0              4.0      120.0        28.0          4.0     112.0       (8.0) copy, or take away copies of records) 26.821(b): Written agreement between C/Vs and licensees to Updated  permit authorized NRC representatives to inspect, copy, or        1.0              4.0          4.0        1.0        4.0        4.0        -
take away copies of C/Vs documents, records, and reports Table 2 Total                                314,177.4                          220,886.5  (93,290.9)
                                                                                                                                                          -29.7%
Page 14 of 24


26.417(b)(2) from a reactor construction site D&A testing  
FINAL Supporting Statement, 10 CFR Part 26 Approved Clearance Values                                                                      Extension Table 3: Annual Reporting                                                  (approved 11/30/14 - ICR 201407-3150-007)                                                            (2017-2020)                                  Burden Index Key:                                                                    Responses                        Burden per        Total                          Responses                      Burden per      Total      Estimate Number                              Total                                          Number                              Total
- Updated  Section                                                                per                          Response        Burden                              per                        Response      Burden      Change of Respondents                        Responses                                    of Respondents                        Responses
- Removed                                                                      Respondent                          (hours)        Hours                          Respondent                        (hours)      Hours 26.9: Application to NRC for exemption                        0              1.0              -                -              -                  0            1.0              -              -          -            -
Updated 26.77(c) Report impaired NRC employee                      30.0                  -              -              1.0              -                  0              -              -            1.0          -            -
26.137(b)(3): Report false negative LTF                                                                                                              No LTF conducts validity screening testing Updated                                                              Burden accounted for under section 26.719(c)(3)                                                                                                                -
validity screening result                                                                                                            (if any did, burden would be accounted for under section 26.719(c)(3) 26.139(d): Prepare information from LTF for                                                                                                                          REMOVED Removed                                                              Burden accounted for under section 26.717(e) and (f)                                                                                                            -
annual FFD program performance report                                                                                                                      (Activity covered in Table 2) 26.187(f): Provide SAE qualifications                                                                                                                                REMOVED Removed                                                              1.0              1.0            1.0              1.0            1.0                                                                                        (1.0) documentation to NRC upon request                                                                                                                          (Activity covered in Table 2) 26.203(e)(1): Prepare information on waivers of work hour controls for inclusion Updated                                                            23.0              1.0            23.0            50.0      1,150.0                21.0              1.0          21.0          50.0    1,050.0      (100.0) in FFD program performance report to NRC required by 26.717 26.203(e)(2): Prepare summary of fatigue                                                                      6.0 corrective actions for inclusion in FFD Updated                                                            23.0              1.0            23.0                          138.0                21.0              1.0          21.0            6.0      126.0        (12.0) program performance report to NRC required by 26.717 26.417(b)(1): Report to NRC by telephone within 24 hours of identifying a Updated                                                              2.0              1.0            2.0              4.0            8.0                  Burden accounted for under section 26.719(b)                         (8.0) programmatic failure in a reactor construction site D&A testing program 26.417(b)(2): Prepare annual FFD program Updated performance report for reactor construction                  2.0            1.0              2.0            80.0        160.0                2.0              1.0            2.0          80.0        160.0            -
site D&A testing program Burden accounted for under section 26.717(e) and (f). NRC's 2012 FFD program 26.717(d): Report termination drug and Removed Removed  alcohol test results in annual program        performance indicate 1,089 positive, adulterated, substituted, and refusal to test                                                                                            -
(All burden is captured under a single 26.717 line items for D&A results) performance summary by processing stage results.
26.717: Annual FFD program performance Updated                                                            62.0              1.0            62.0              8.0        496.0                59.0              1.0          59.0            8.0        472.0        (24.0) report for fatigue management programs 26.717: Annual FFD program performance Updated                                                            65.0              1.0            65.0            60.0      3,900.0                67.0              1.0          67.0          60.0      4,020.0        120.0 for D&A testing programs 26.719(a): Report a significant FFD Updated program violation, programmatic failure, or                Burden accounted for under section 26.719(b) and (c)                            Burden reported under sections 26.719(b), and (c)(1) - (c)(3)                    -
D&A testing error 26.719(b): Report to the NRC by telephone Updated within 24 hours of identifying a significant              15.0              2.5            37.1              4.0        148.2                37.0              1.0          37.0            4.0        148.0        (0.2)
D&A testing violation 26.719(c)(1): Submit a report to the NRC within 30 days of completing an Updated                                                              6.0              1.0            6.0            24.0        144.0                8.0              1.0            8.0          24.0        192.0          48.0 investigation into an LTF or HHS lab testing error 26.719(c)(2): Notify the NRC by telephone Updated within 24 hours of receiving notice of a false              1.0              1.0            1.0              4.0            4.0                  0            1.0              -            4.0            -        (4.0) positive on a BPTS test result 26.719(c)(3): Notify the NRC by telephone within 24 hours of receiving a false negative Updated                                                              4.0              1.0            4.0              4.0          16.0                    0            1.0              -            4.0            -      (16.0) test result on a QA check of a validity screening test from an LTF Table 3 Total                                              226.1                      6,165.2                                                215.0                    6,168.0          2.8 Page 15 of 24


program.                   2.0              25.0              50.0                 2.0            25.0        50.0 -
FINAL Supporting Statement, 10 CFR Part 26 Table 4: Annual Third-Party Disclosure                                                Approved Clearance Values                                Extension (approved 11/30/14 - ICR 201407-3150-007)                      (2017-2020)
Updated Annual fatigue management performance report --
Index Key:
Review, analyze, and summarize fatigue management data
- Consolidated                                                                                                                                                              Burden
- Duplicative                                                                                                    Total                                          Total    Estimate Number          Burden                                          Burden
- Moved        Section                                                                                        Annual          Number                          Annual    Change of        Hours per                                        Hours per
- New                                                                                                          Burden      of Responses                        Burden Responses      Response                                        Response
- Removed                                                                                                        Hours                                          Hours
- Updated 26.4(j): For personnel granted authorization by a licensee, who are covered by a D&A testing program regulated by a State or Federal agency - (1) provision of training record to the licensee to demonstrate section 26.29(a) training Updated    requirements met (if not already covered in the existing                14.0            2.0            28.0            33.5            2.0          67.0        39.0 program); (2) notification of any FFD policy violations by those granted authorization by the licensee or other entity Moved    26.29(b): Complete initial training on FFD policy and take              Not included in clearance 81,219.3            2.0    162,438.6    162,438.6 (from Table 1) comprehensive examination                                          (was in Table 1 but zero programs)
Moved    26.29(c)(2): Complete annual refresher training on FFD                  Not included in clearance 103,932.7              1.5    155,899.0    155,899.0 (from Table 1) policy                                                            (was in Table 1 but zero programs) 26.31(b)(1)(i): Individual applying for access to serve as FFD program personnel provides background check Updated    information for the background investigation, credit and            93,890.0            1.0      93,890.0            335.0              1.0        335.0  (93,555.0) criminal history checks, and psychological assessment 26.31(d)(6): Donor provides written permission to conduct                                                                      Removed Removed                                                                              8.0            1.0            8.0                                                        (8.0) another analysis or test with specimen                                                                              (not an information collection)
Updated    26.35(a): Employee assistance program (EAP) records                    14.0          32.0          448.0            26.0            32.0          832.0        384.0 26.35(c): Individual completes and provides the EAP with a Updated    written waiver of right to privacy to share information with        5,636.0            0.3        1,690.8          1,039.3            0.25         259.8    (1,431.0)
FFD management 26.35(c): Record of EAP disclosure to FFD management Updated                                                                            15.0            1.0            15.0            13.0              1.0         13.0        (2.0) about an individual that poses an immediate hazard 26.37(b): Individuals provide signed consent for release of Updated                                                                        1,127.0            0.3          338.1           258.0            0.25           64.5      (273.6) information 26.37(b)(1): Individual provides signed designation of Updated                                                                          961.0            1.0          961.0           258.0            0.25          64.5      (896.5) personal representative for an FFD matter 26.37(d): Request by donor or donors presentative to the Updated    licensee or other entity to provide personal records collected         961.0            1.0         961.0            26.0          0.25            6.5      (954.5) under Part 26 26.53(h): Applicant provides written consent before any Updated                                                                        93,890.0            0.3      28,167.0        81,219.3            0.25      20,304.8    (7,862.2) actions are initiated under Subpart C of Part 26 26.55(a)(1) - (a)(2): Initial authorization 26.57(a)(1) - (a)(2): Authorization update 26.59(a)(1) - (a)(2): Authorization reinstatement                      Burden accounted for under                      Burden accounted for under Updated    Each individual applying for authorization must complete a                                                                                                            -
sections 26.61 and 26.63              sections 26.61(a) and 26.63(a),(c) and (e) self-disclosure, employment history, and suitable inquiry 26.59(c)(1): Applicant prepares self-disclosure (for Burden accounted for under                      Burden accounted for under Updated    authorization reinstatement period of interruption of no more                                                                                                        -
section 26.61                                sections 26.61(a) than 30 days) 26.61(a): Applicant prepares self-disclosure and Updated                                                                        93,890.0            1.0      93,890.0        81,219.3              1.0      81,219.3  (12,670.7) employment history 26.63(a), (c), and (e): Former employer(s) provide information to the licensee or other entity to verify an Updated    applicants suitable inquiry information on previous                93,890.0          0.80        75,112.0        81,219.3            0.75      60,914.5  (14,197.5) authorization(s) 26.63(c)(2): U.S. Department of Defense (DOD) provides                                                      Burden of supplying DD 214 affects DOD, or Updated   licensee or other entity with form DD 214 which details an      Burden of supplying DD 214 affects DOD        is accounted for under section 26.61(a) (if            -
applicants military service record                                                                                    supplied by the applicant) 26.63(c)(3): Former employer refuses to provide information Updated    to the licensee or other entity about an applicants prior            180.0            0.5            90.0          180.0              0.1          15.0        (75.0) employment history 26.67: Records of random D&A testing of persons who have Updated    applied for authorization, but who have not been granted              335.0            0.5          167.5            406.1              0.5        203.0        35.55 unescorted access authorization 26.69(b) and (c)(1): Applicant provides written self-disclosure and employment history to the licensee or other entity (for authorization following a 1st or 2nd positive drug        Burden accounted for under                      Burden accounted for under Updated                                                                                                                                                                          -
or alcohol test result, or if other PDI is identified)                        section 26.63                                  section 26.61(a) 26.69(c)(2): Former employer(s) of an applicant provide Updated    response to licensee or other entity request to confirm                939.0            2.0        1,878.0            812.2              2.0      1,624.4      (253.6) suitable inquiry information for an applicant with PDI 26.85(c): Alternative collectors not employed by licensee Updated                                                                            22.0            1.0            22.0            26.0            1.0          26.0          4.0 provide proof of qualification 26.85(e): Maintain personnel files for alternative collectors Updated                                                                            22.0            4.0            88.0            26.0            4.0        104.0        16.0 Page 16 of 24


specified in section 26.201(e) that is submitted under section  
FINAL Supporting Statement, 10 CFR Part 26 Table 4: Annual Third-Party Disclosure                                                Approved Clearance Values                            Extension (approved 11/30/14 - ICR 201407-3150-007)                  (2017-2020)
Index Key:
- Consolidated                                                                                                                                                          Burden
- Duplicative                                                                                                  Total                                        Total    Estimate Number        Burden                                      Burden
- Moved        Section                                                                                        Annual        Number                        Annual    Change of        Hours per                                  Hours per
- New                                                                                                          Burden      of Responses                      Burden Responses      Response                                    Response
- Removed                                                                                                      Hours                                        Hours
- Updated 26.87(f)(1), and (f)(3) - (f)(5): Post a sign outside the collection area (if a public restroom) and document on the custody-and-control form (CCF) the name of a same gender Consolidated observer (in the exceptional event that a designated                      2.0            1.0            2.0          Consolidated in Table 2                    (2.0)
(in Table 2) collection site is inaccessible, the collector is not the same gender as the donor and a urine specimen must be immediately collected) 26.89(a): Record that a donor did not appear for testing (non Updated                                                                              2.0            1.0            2.0          2.0            1.0            2.0          -
licensee collection site) 26.89(b)(3): Record FFD management informed that an Updated    individual did not present identification (non-licensee                  2.0            1.0            2.0          2.0            1.0            2.0          -
collection site) 26.89(c): Record that FFD management informed that a Updated    donor refused to cooperate with the collection procedures                2.0            1.0            2.0              -          0.25              -        (2.0)
(non-licensee collection site) 26.91(e)(4): Record that results cancelled after EBT Updated                                                                              1.0            1.0            1.0              -          1.0              -        (1.0) calibration check failure (non-licensee collection site) 26.91(e)(5): Prepare record of EBT maintenance (non-Updated                                                                            22.0            4.0          88.0          26.0            4.0          104.0        16.0 licensee collection site) 26.93(a)(6): Document alcohol pre-test questions asked and Updated                                                                            280.0            0.3          84.0        260.0          0.25          65.0        (19.0) answered (non-licensee collection site) 26.95(b)(5): Record donor identity for initial alcohol breath Updated                                                                            280.0            0.3          84.0        260.0          0.25          65.0        (19.0) test (non-licensee collection site) 26.97(b)(2): Record reason for new oral fluid alcohol test Updated                                                                              8.0            0.5            4.0              -          0.5              -        (4.0)
(non-licensee collection site) 26.97(c)(1): Document reason for failure of second Updated                                                                              1.0            1.0            1.0              -          1.0              -        (1.0) collection attempt (non-licensee collection site) 26.97(d): Record results and alcohol screening device used Updated                                                                              8.0            0.3            2.4              -          0.25              -      (2.40)
(non-licensee collection site)
Duplicative  26.99(b): Record test time of initial test with 0.02 percent                                                      Burden accounted for under 1.0            0.3            0.3                                                    (0.30)
Burden    BAC or higher (non-licensee collection site)                                                                          section 26.715(b)(2)
Duplicative  26.101(b)(7): EBT printout of confirmatory alcohol test result                                                    Burden accounted for under 1.0            0.3            0.3                                                    (0.30)
Burden    includes time of test (non-licensee collection site)                                                                  section 26.715(b)(2) 26.103(b): Collector informs FFD management of result Updated    between 0.01 and 0.02 percent BAC when donor in work                        -            0.5              -              -          0.25              -          -
status 3 or more hours (non-licensee collection site)
Duplicative  26.107(b): Collector documents tampering attempt on CCF                                                            Burden accounted for under
                                                                                          -            1.0              -                                                      -
Burden    form (non-licensee collection site)                                                                                    section 26.111(b) 26.109(b)(3): Collector documents on CCF sh- bladder Updated    situation and notifies FFD management (non-licensee                        -            0.5              -              -          0.25              -          -
collection site) 26.109(b)(4): Collector documents on CCF confirmation Updated    from FFD management to conduct a an observed collection                    -            0.3              -              -          0.25              -          -
(non-licensee collection site) 26.111(b): Collector documents on CCF if specimen Updated    characteristics (color, clarity) indicate possible tampering by          2.0            0.5            1.0              -          0.25              -        (1.0) the donor (non-licensee collection site) 26.111(c): Collector documents on CCF unusual specimen temperature and/or other observations made during the Updated    collection of possible tampering attempt and notifies FFD                  -            0.4              -                        0.25              -          -
management (non-licensee collection site)
Duplicative  26.113(b)(3): Collector completes CCF for split-specimen                                                          Burden accounted for under
                                                                                          -            0.3              -                                                      -
Burden    collection (non-licensee collection site)                                                                            section 26.117(c) - (e) 26.115(b): Collector documents on CCF approval from FFD Updated    manager or MRO to collect a specimen under direct                          -            0.3              -              -          0.25              -          -
observation (non-licensee collection site) 26.115(d): Collector documents on CCF directly observed Burden accounted for under Updated    collection performed and the reason for the observed                        -            0.3              -                                                      -
section 26.115(b) collection (non-licensee collection site) 26.115(f)(3): Record of name of observer (non-licensee
                                                                                          -            0.3              -              -          0.25              -          -
collection site) 26.117(c) - (e): Collector prepares ID labels and CCF forms Updated    for specimen shipment (non-licensee collection site)                    280.0            0.3          84.0        260.0          0.25          65.0        (19.0) 26.119(a), (e), and (f): Physician evaluating shy-bladder Updated    claim prepares report of medical examination of donor and                  -            6.0              -          13.0            2.0          26.0        26.0 provides this information to the MRO Consolidated 26.119(b): MRO provides information to physician as
                                                                                          -            2.0              -          Consolidated in Table 2                      -
(in Table 2) background for evaluation of a shy bladder claim 26.129(b): Collector prepares memorandum to and sends to Updated    LTF documenting investigation of discrepancies between                      -            1.0              -                          1.0              -          -
bottles and CCF (non-licensee collection site)
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26.717                  62.0             10.0            620.0                59.0            10.0       590.0 (30.0)
FINAL Supporting Statement, 10 CFR Part 26 Table 4: Annual Third-Party Disclosure                                                Approved Clearance Values                              Extension (approved 11/30/14 - ICR 201407-3150-007)                    (2017-2020)
Updated Annual FFD program performance report -
Index Key:
Review, analyze, and summarize information received under  
- Consolidated                                                                                                                                                            Burden
- Duplicative                                                                                                    Total                                        Total    Estimate Number        Burden                                        Burden
- Moved        Section                                                                                          Annual        Number                        Annual    Change of        Hours per                                      Hours per
- New                                                                                                            Burden      of Responses                      Burden Responses      Response                                      Response
- Removed                                                                                                        Hours                                        Hours
- Updated 26.135(b): Donor request to MRO for the retesting of an aliquot of a single specimen or the testing of the Bottle B                                                          Burden accounted for under Updated    split specimen at a second HHS lab (initial specimen testing              1.0            0.5            0.5                                                    (0.50) section 26.165(b)(1) performed at an LTF) 26.137(b)(3): LTF records submitting 1 in 10 negative                                                                    Not Third Party Burden Removed    specimens for validity screening to HHS lab                                  -          40.0              -                                                      -
(accounted for in Table 2) 26.153(g): Supply memorandum to HHS lab explaining use Updated    of non-federal CCF form (non-licensee collection site)                    2.0            0.5            1.0            2.0             0.5          1.0         -
26.155(a)(1): Document of HHS lab manager qualifications Burden covered by HHS lab certification      Burden covered by HHS lab certification Updated                                                                                                                                                                        -
requirements OMB Clearance # 0930-0158      requirements OMB Clearance No. 0930-0158 26.155(a)(3): HHS lab personnel training documentation Burden covered by HHS lab certification      Burden covered by HHS lab certification Updated                                                                                                                                                                        -
requirements OMB Clearance # 0930-0158      requirements OMB Clearance No. 0930-0158 26.155(a)(4): HHS lab manager reviews and approved lab Burden covered by HHS lab certification      Burden covered by HHS lab certification Updated   procedures                                                                                                                                                          -
requirements OMB Clearance # 0930-0158      requirements OMB Clearance No. 0930-0158 26.155(a)(5): HHS lab manager maintains QA program Burden covered by HHS lab certification      Burden covered by HHS lab certification Updated                                                                                                                                                                        -
requirements OMB Clearance # 0930-0158      requirements OMB Clearance No. 0930-0158 26.155(b): Certifying scientist at HHS lab certifies test Burden covered by HHS lab certification      Burden covered by HHS lab certification Updated    results                                                                                                                                                            -
requirements OMB Clearance # 0930-0158      requirements OMB Clearance No. 0930-0158 26.155(c): Supervise technical analysts at HHS lab Burden covered by HHS lab certification      Burden covered by HHS lab certification
                                                                                                                                                                                  -
requirements OMB Clearance # 0930-0158      requirements OMB Clearance No. 0930-0158 26.155(e): Continuing education of HHS lab staff Burden covered by HHS lab certification      Burden covered by HHS lab certification Updated                                                                                                                                                                        -
requirements OMB Clearance # 0930-0158      requirements OMB Clearance No. 0930-0158 26.155(f): HHS lab personnel records Burden covered by HHS lab certification      Burden covered by HHS lab certification Updated                                                                                                                                                                        -
requirements OMB Clearance # 0930-0158      requirements OMB Clearance No. 0930-0158 26.157(a): Written HHS lab procedures for accession, Burden covered by HHS lab certification      Burden covered by HHS lab certification Updated    receipt, shipment, and testing of urine specimens                                                                                                                  -
requirements OMB Clearance # 0930-0158      requirements OMB Clearance No. 0930-0158 26.157(b): Written HHS lab chain-of-custody procedures for Burden covered by HHS lab certification      Burden covered by HHS lab certification HHS lab                                                                                                                                                            -
requirements OMB Clearance # 0930-0158      requirements OMB Clearance No. 0930-0158 26.157(c): Written HHS lab procedures for each testing Burden covered by HHS lab certification      Burden covered by HHS lab certification Updated    assay performed                                                                                                                                                    -
requirements OMB Clearance # 0930-0158      requirements OMB Clearance No. 0930-0158 26.157(d): Written HHS lab procedures for device set-up Burden covered by HHS lab certification      Burden covered by HHS lab certification Updated    and operation                                                                                                                                                      -
requirements OMB Clearance # 0930-0158      requirements OMB Clearance No. 0930-0158 26.157(e): Written HHS lab procedures for remedial actions Burden covered by HHS lab certification      Burden covered by HHS lab certification Updated    to address system and instrument errors                                                                                                                            -
requirements OMB Clearance # 0930-0158      requirements OMB Clearance No. 0930-0158 26.159(a): Retain records (e.g., an access log) of authorized Burden covered by HHS lab certification      Burden covered by HHS lab certification Updated    visitors, maintenance personnel, and service personnel who                                                                                                          -
requirements OMB Clearance # 0930-0158      requirements OMB Clearance No. 0930-0158 accessed secure areas of HHS lab 26.159(b)(1): Record that the HHS lab notified the licensee NEW      or other entity within 24 hours of identifying evidence of          Not included in previous clearance                    0            1.0            -
specimen tampering 26.159(c) - (e): Use and storage of CCF forms at HHS lab          Burden covered by HHS lab certification            Burden accounted for under Updated                                                                                                                                                                        -
requirements OMB Clearance # 0930-0158                  section 26.715(b)(2) 26.159(f): Use of CCF by HHS lab when shipping a                  Burden covered by HHS lab certification            Burden accounted for under Updated                                                                                                                                                                        -
specimen to another HHS lab                                      requirements OMB Clearance # 0930-0158                  section 26.165(b)(1) 26.165(b)(1): At the direction of the MRO, the initial HHS lab that conducted testing send a donors specimen (i.e., an Updated    aliquot of a single specimen or Bottle B of the split                      1.0            1.0            1.0          31.1            1.0          31.1        30.1 specimen) to a second HHS lab for further testing 26.165(b)(2): Record that MRO informed the donor of the Consolidated opportunity to request the retesting of an aliquot of a single 1.0            0.3            0.3          Consolidated in Table 2                  (0.30)
(in Table 2) specimen or the testing of the Bottle B split specimen at a second HHS lab 26.165(b)(3): Donor provides written request to the MRO for Updated    the retesting of an aliquot of a single specimen or the testing            1.0            1.0            1.0          31.1            1.0          31.1        30.1 of the Bottle B split specimen 26.165(b)(4): Donor presents documentation to the MRO on Duplicative                                                                                                                        Burden accounted for under the reason for not being able to make a timely retest request                -            1.0              -                                                      -
Burden                                                                                                                              section 26.185(e)
Page 18 of 24


26.717 from a D&A testing program                 65.0              25.0        1,625.0               67.0            12.0      804.0 (821.0)         Removed Review reports under section 26.719(a) of significant violations of FFD policy, D&A testing program failures, and  
FINAL Supporting Statement, 10 CFR Part 26 Table 4: Annual Third-Party Disclosure                                                  Approved Clearance Values                              Extension (approved 11/30/14 - ICR 201407-3150-007)                      (2017-2020)
Index Key:
- Consolidated                                                                                                                                                                Burden
- Duplicative                                                                                                        Total                                        Total      Estimate Number        Burden                                          Burden
- Moved        Section                                                                                              Annual        Number                        Annual      Change of        Hours per                                      Hours per
- New                                                                                                              Burden      of Responses                    Burden Responses      Response                                      Response
- Removed                                                                                                          Hours                                        Hours
- Updated 26.165(b)(6) HHS lab provides report to the MRO of the Duplicative  quantitative test results of the retesting of aliquot of a single                                                        Burden accounted for under specimen or the testing of the Bottle B split specimen                      1.0            0.5            0.5                                                    (0.50)
Burden                                                                                                                                  section 26.185(n) 26.167(a): HHS lab documents QA program (encompasses Burden covered by HHS lab certification        Burden covered by HHS lab certification Updated    all aspects of the testing process)                                                                                                                                    -
requirements OMB Clearance # 0930-0158        requirements OMB Clearance No. 0930-0158 26.167(c)(2)(i): Refractometer at the HHS lab must display specific gravity to 4 decimals and be interfaced with laboratory information management system or computer                Burden covered by HHS lab certification        Burden covered by HHS lab certification
                                                                                                                                                                                      -
and/or document result by hard copy or electronic display          requirements OMB Clearance # 0930-0158        requirements OMB Clearance No. 0930-0158 26.167(f)(3): False positive error on BPTS test and the error is technical or methodological, the HHS lab Responsible Person must document that retesting of all positive, adulterated, substituted, and invalid specimens from the            Burden covered by HHS lab certification Updated    time of final resolution of the error back to the time of the                                                                  -          8.0              -          -
requirements OMB Clearance # 0930-0158 last satisfactory performance test cycle has been completed, as requested by the licensee or other entity 26.167(h): HHS lab labels standards and controls Burden covered by HHS lab certification        Burden covered by HHS lab certification Updated                                                                                                                                                                          -
requirements OMB Clearance # 0930-0158        requirements OMB Clearance No. 0930-0158 26.168(a): Blind performance test sample (BPTS) supplier provides HHS lab certification letter of BPTS formulation to        Burden covered by HHS lab certification Updated                                                                                                                                2.0            8.0          16.0        16.0 licensee or other entity                                          requirements OMB Clearance # 0930-0158 26.168(h)(2): BPTS sample supplier provides expiration Burden covered by HHS lab certification Updated    date on each BPTS                                                                                                          2.0            8.0          16.0        16.0 requirements OMB Clearance # 0930-0158 26.168(i)(2): Licensee or other entity completes CCF for a Moved    BPTS, places fictional initials on specimen labels, and              Burden covered by HHS lab certification indicates on the MRO copy of the CCF that the specimen is                                                                    Moved to Table 2                        -
(to Table 2)                                                                    requirements OMB Clearance # 0930-0158 a BPTS 26.169(a): HHS lab reports test results to the MRO of the            Burden covered by HHS lab certification            Burden accounted for under Updated    licensee or other entity                                                                                                                                              -
requirements OMB Clearance # 0930-0158                    section 26.169(c)(1) 26.169(c)(1): HHS lab provides record to the MRO for each Updated    positive, adulterated, substituted, dilute, and invalid test              686.0            0.25         171.5          621.0           0.25         155.3        (16.3) result Duplicative  26.169(c)(2): HHS lab provides quantitative test result                                                                  Burden accounted for under 5.0            1.0            5.0                                                    (5.0)
Burden    record for positive drug test (at the request of the MRO)                                                                    section 26.169(c)(1)
Duplicative  26.169(c)(2): HHS lab record of quantitative test results for                                                            Burden accounted for under 16.0            1.0            16.0                                                    (16.0)
Burden    opiates to the MRO (at the request of the MRO)                                                                              section 26.169(c)(1) 26.169(c)(3): HHS lab provides quantitative test result Duplicative                                                                                                                          Burden accounted for under record for adulterated or substituted test results (at the                  5.0            1.0            5.0                                                    (5.0)
Burden                                                                                                                                section 26.169(c)(1) request of the MRO) 26.169(c)(4): HHS lab record of contact with MRO to Updated    discuss if additional testing by another HHS lab should be                  10.0            0.5            5.0          10.0            0.5            5.0          -
conducted on a specimen with an invalid test result 26.169(f): HHS lab transmits to the MRO a copy of CCF for                                                                Burden accounted for under Updated                                                                                Electronic transmission                                                                  -
specimens with negative test results                                                                                        section 26.715(b)(2) 26.169(g): HHS lab transmits to the MRO a copy of the Duplicative  original CCF signed by the certifying scientist (for positive,                                                          Burden accounted for under adulterated, substituted, dilute and invalid test result)                  686.0            0.5          343.0                                                   (343.0)
Burden                                                                                                                                section 26.169(c)(1) 26.169(h): HHS lab prepares and submits annual statistical Updated    summary report of urinalysis testing results                                10.0            40.0          400.0            67.0            2.0        134.0      (266.0)
Consolidated 26.183(a): Documentation of MRO qualifications 28.0            1.0            28.0           Consolidated in Table 2                  (28.0)
(in Table 2) 26.183(c)(1): MRO review of records for positive, Consolidated adulterated, substituted, invalid, or, at the licensees or other Burden accounted for under section 26.185(a)            Consolidated in Table 2                    -
(in Table 2) entity's discretion, dilute test results that confirm as an FFD violation Consolidated  26.183(d)(2)(i): Record of MRO staff review and reporting of 16,383.0              0.1          819.2            Consolidated in Table 2                (819.15)
(in Table 2) negative test results Consolidated  26.183(d)(2)(ii): Record of MRO staff review of CCF forms 54.0            0.1            5.4          Consolidated in Table 2                  (5.40)
(in Table 2) and forward changes to MRO 26.185(a) Record of MRO review of all positive, adulterated, Consolidated substituted, or invalid test results and report to licensee or            635.0            1.0          635.0            Consolidated in Table 2                (635.0)
(in Table 2) other entity 26.185(c): Donor discussion with MRO of positive, Updated                                                                              635.0            1.0          635.0          621.0            0.5        310.5      (324.5) adulterated, substituted, dilute, or invalid test result Page 19 of 24


errors in laboratory testing Burden reported under section 26.719 (b) and (c)  REMOVED -
FINAL Supporting Statement, 10 CFR Part 26 Table 4: Annual Third-Party Disclosure                                                Approved Clearance Values                               Extension (approved 11/30/14 - ICR 201407-3150-007)                     (2017-2020)
Table 5: Annualized NRC Burden Approved Clearance Values (approved 11/30/14 - ICR 201407-3150-007)
Index Key:
Extension (2017-2020)
- Consolidated                                                                                                                                                              Burden
Burden Estimate Change Page 22 of 24 FINAL Supporting Statement, 10 CFR Part 26 Index Key:- Updated- Consolidated
- Duplicative                                                                                                    Total                                          Total    Estimate Number          Burden                                          Burden
- Removed NRC ACTION No. Actions/
- Moved        Section                                                                                          Annual        Number                          Annual    Change of         Hours per                                      Hours per
Year Burden Hours / Action Total Hours No. Actions/
- New                                                                                                            Burden      of Responses                        Burden Responses      Response                                      Response
Year Burden Hours / Action Total Hours Table 5: Annualized NRC Burden Approved Clearance Values (approved 11/30/14 - ICR 201407-3150-007)
- Removed                                                                                                        Hours                                          Hours
Extension (2017-2020)
- Updated Consolidated 26.185(d)(1): Documentation that donor declined to discuss 81.0            1.0            81.0          Consolidated in Table 2                    (81.0)
Burden Estimate Change Updated 24-hour report -- Review, evaluate, and respond to a report made under section 26.719(b) to the NRC Operations Center
(in Table 2) test results 26.185(e): Donor provides documentation to the MRO Updated    demonstrating an inability to discuss test results and                    8.0          1.0              8.0            8.0              1.0            8.0          -
requesting the test result determination be reopened 26.185(f)(1): HHS lab consultation with MRO on whether Burden accounted for under Updated    additional testing of a specimen with an invalid test result                                                            26.0            0.50          13.0        13.0 section 26.185(c) should be performed at a second HHS lab 26.185(f)(2): Donor discussion with MRO regarding an                    Burden accounted for under                    Burden accounted for under Updated                                                                                                                                                                           -
invalid test result                                                          section 26.185(c)                              section 26.185(c) 26.185(h)(1): Donor discussion with MRO regarding a                    Burden accounted for under                    Burden accounted for under Updated                                                                                                                                                                          -
substituted test result                                                      section 26.185(c)                              section 26.185(c)
Consolidated 26.185(h)(2): MRO notification to licensee that no valid Burden accounted for under section 26.185(c)            Consolidated in Table 2                        -
(in Table 2) medical explanation presented Consolidated 26.185(h)(3): MRO notification to licensee that valid medical Burden accounted for under section 26.185(c)            Consolidated in Table 2                        -
(in Table 2) explanation presented 26.185(i)(1): Donor discussion with MRO regarding an                    Burden accounted for under                    Burden accounted for under Updated                                                                                                                                                                          -
adulterated test result                                                      section 26.185(c)                              section 26.185(c)
Consolidated 26.185(i)(2): MRO notification to licensee that no valid Burden accounted for under section 26.185(c)            Consolidated in Table 2                        -
(in Table 2) medical explanation presented 26.185(i)(3): MRO notification to licensee that valid medical Consolidated explanation presented for an adulterated test result            Burden accounted for under section 26.185(c)           Consolidated in Table 2                        -
(in Table 2) 26.185(j) Donor discussion with MRO regarding a positive test result from use of a prescription medication (amphetamine, morphine, codeine), and donor provides                    Burden accounted for under Updated   documentation on medication use to the MRO (e.g.,                                                                      60.0              1.0        60.0        60.0 section 26.185(c) prescription information and pharmacy, prescribing physician information)
Consolidated 26.185(k): MRO report to licensee that no FFD policy 24.0            1.0            24.0          Consolidated in Table 2                    (24.0)
(in Table 2) violation has occurred 26.185(m): MRO review of inspection and audit reports, quality control data, multiple specimens, and other data to Consolidated determine if positive, adulterated, substituted, or invalid 24.0            1.0            24.0          Consolidated in Table 2                    (24.0)
(in Table 2) result is scientifically insufficient for determination of FFD policy violation 26.185(n): Second HHS lab provides the MRO with test Updated    result report (for retesting of an aliquot of a single specimen          54.0            1.0            54.0          31.1            0.25            7.8      (46.2) or the testing of a Bottle B split specimen) 26.185(o): HHS lab provides report with quantitative test Duplicative  results for a specimen from a donor applying for reauthorization following a 1st positive drug test result (at              8.0          0.5              4.0          Duplicate with row below                    (4.0)
Burden MRO request) 26.185(o): HHS lab provides quantitation of test results for Duplicative  testing performed on a specimen from a donor applying for                                                            Burden accounted for under reauthorization following a 1st positive drug test result (at              8.0          1.0              8.0                                                      (8.0)
Burden                                                                                                                              sections 26.169(c)(1)
MRO request)
Consolidated  26.185(p): MRO notice to licensee of determination of FFD Burden accounted for under section 26.185(c)            Consolidated in Table 2                      -
(in Table 2) policy violation Consolidated  26.187(d): SAE training requirements 24.0          20.0            480.0          Consolidated in Table 2                  (480.0)
(in Table 2)
Consolidated  26.187(f): Documentation of SAE credentials and training 24.0            1.0            24.0          Consolidated in Table 2                    (24.0)
(in Table 2) 26.189(b): If a qualified treatment professional other than the MRO or SAE performs a determination of fitness on an Updated    individual, that treatment professional completes and                    69.0            1.0            69.0          26.0                1.0        26.0        (43.0) provides a written determination to the MRO Consolidated  26.189(c): Written record of a For-cause determination of 6.9          1.0              6.9            Consolidated in Table 2                  (6.90)
(in Table 2) fitness Consolidated  26.189(d): Modification of an initial determination of fitness 24.0            1.0            24.0            Consolidated in Table 2                  (24.0)
(in Table 2) based on information from other sources 26.209(a): Individual declares that due to fatigue, he or she Updated    is unable to safety and competently perform his or her                  23.0            0.3              6.9          21.0              0.3          6.3      (0.60) duties 26.405(g): For a reactor construction site FFD program, MRO reports of positive, adulterated, substituted, or invalid                                                                  Removed Removed    drug test results (for a reactor construction site FFD D&A              90.0            1.0            90.0                                                      (90.0)
(This is not third-party burden) testing program) 26.411(b): Applicant provides written consent to the reactor Updated    construction site D&A testing program                                4,675.0            0.3          1,402.5        6,898.0            0.25      1,724.5      322.00 26.715(a): Documentation of all aspects of HHS lab testing Previously accounted for in Table 2        Burden covered by HHS lab certification NEW      process, not specified elsewhere in section 26.715(b)                                                                                                                -
as Annualized Burden              requirements OMB Clearance No. 0930-0158 Page 20 of 24


regarding a significant FFD policy violation or programmatic
FINAL Supporting Statement, 10 CFR Part 26 Table 4: Annual Third-Party Disclosure                                            Approved Clearance Values                              Extension (approved 11/30/14 - ICR 201407-3150-007)                    (2017-2020)
Index Key:
- Consolidated                                                                                                                                                          Burden
- Duplicative                                                                                                  Total                                      Total      Estimate Number          Burden                                        Burden
- Moved        Section                                                                                        Annual        Number                      Annual      Change of          Hours per                                    Hours per
- New                                                                                                        Burden      of Responses                  Burden Responses      Response                                    Response
- Removed                                                                                                      Hours                                      Hours
- Updated 26.715(b)(1): Retain personnel files on HHS lab staff Previously accounted for in Table 2        Burden covered by HHS lab certification NEW                                                                                                                                                                        -
as Annualized Burden              requirements OMB Clearance No. 0930-0158 26.715(b)(2): Retain HHS lab chain-of-custody documents          Previously accounted for in Table 2 NEW                                                                                                                              9.0        240.0        2,160.0    2,160.00 as Annualized Burden 26.715(b)(3): Retain HHS lab QA/QC records Previously accounted for in Table 2        Burden covered by HHS lab certification NEW                                                                                                                                                                        -
as Annualized Burden              requirements OMB Clearance No. 0930-0158 26.715(b)(4): Retain HHS lab superseded procedures                Previously accounted for in Table 2 NEW                                                                                                                              9.0          40.0          360.0      360.00 as Annualized Burden 26.715(b)(5) Retain all test data from HHS lab (including Previously accounted for in Table 2        Burden covered by HHS lab certification NEW        calibration curves and any calculations used in determining                                                                                                    -
as Annualized Burden              requirements OMB Clearance No. 0930-0158 test results) 26.715(b)(6): HHS lab test reports                                Previously accounted for in Table 2 NEW                                                                                                                              9.0        240.00        2,160.0    2,160.00 as Annualized Burden 26.715(b)(7): HHS lab performance testing records Previously accounted for in Table 2        Burden covered by HHS lab certification NEW                                                                                                                                                                        -
as Annualized Burden              requirements OMB Clearance No. 0930-0158 26.719(c): HHS lab provides information to the licensee or Updated    other entity on investigation completed on a testing error              6.0          8.0            48.0            8.0          8.0            64.0      16.00 (information for 30-day event report to NRC) 26.821(b): Written agreement between C/Vs and licensees to permit authorized NRC representatives to inspect, copy, or take away copies of C/Vs documents, records, and                    5.0          4.0            20.0            5.0          4.0            20.0        -
reports Table 4 Total    410,999.9                      303,559.1      441,569.1                  492,029.4      188,470.3 62.1%
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failure                  37.0              16.0            592.0               37.0              8.0      296.0 (296.0)        Updated 30-day report -- Review, evaluate, and respond to a report made under section 26.719(c) to the NRC detailing the
FINAL Supporting Statement, 10 CFR Part 26 Approved Clearance Values                          Extension Table 5: Annualized NRC Burden                                                (approved 11/30/14 - ICR 201407-3150-007)                (2017-2020)
Burden Index Key:                                                                                                                                                      Estimate Burden                                    Burden
- Updated                                                                        No. Actions/                    Total    No. Actions/                Total    Change NRC ACTION                                                                        Hours /                                    Hours /
- Consolidated                                                                      Year                        Hours          Year                    Hours
- Removed                                                                                          Action                                    Action Updated    Review exemption request under section 26.9                                2.0          16.0        32.0              -        16.0        -    (32.0)
Review FFD policies and procedures under section 26.27(d)
Updated                                                                                12.0            8.0        96.0          12.0          8.0      96.0        -
(performed during periodic inspections)
Review records under section 26.75(h) to ensure only appropriate records maintained for a licensee or other entity Updated    who administratively withdraws access for initial positive drug            12.0            4.0         48.0              -          4.0        -    (48.0) tests for marijuana or cocaine at an LTF (performed during periodic inspections)
Review and evaluate report made under section 26.77(c)
No reports Updated    regarding an NRC employee or contractor being unfit for duty                  -                            -            -          4.0        -        -
anticipated Review documentation provided by SAE upon request by Updated                                                                                1.0            4.0          4.0          1.0          4.0      4.0       -
NRC under section 26.187(f)
Review and evaluate a 24-hour report made under section Burden accounted for under Consolidated 26.417(b)(1) to the NRC Operations Center regarding a                        1.0          16.0        16.0                                           (16.0) section 26.719(b) significant FFD program failure Annual FFD program performance report -
Review, analyze, and summarize information received under Updated                                                                                2.0          25.0        50.0            2.0        25.0      50.0       -
26.417(b)(2) from a reactor construction site D&A testing program.
Annual fatigue management performance report --
Review, analyze, and summarize fatigue management data Updated     specified in section 26.201(e) that is submitted under section            62.0          10.0        620.0          59.0        10.0    590.0      (30.0) 26.717 Annual FFD program performance report -
Updated    Review, analyze, and summarize information received under                  65.0          25.0      1,625.0          67.0        12.0    804.0    (821.0) 26.717 from a D&A testing program Review reports under section 26.719(a) of significant Burden reported under Removed violations of FFD policy, D&A testing program failures, and                                                                    REMOVED                      -
section 26.719 (b) and (c) errors in laboratory testing Page 22 of 24


investigation of any testing errors or unsatisfactory  
FINAL Supporting Statement, 10 CFR Part 26 Approved Clearance Values                      Extension Table 5: Annualized NRC Burden                                                  (approved 11/30/14 - ICR 201407-3150-007)            (2017-2020)
Burden Index Key:                                                                                                                                                  Estimate Burden                                  Burden
- Updated                                                                        No. Actions/                  Total    No. Actions/            Total    Change NRC ACTION                                                                        Hours /                                Hours /
- Consolidated                                                                        Year                      Hours        Year                Hours
- Removed                                                                                          Action                                Action 24-hour report -- Review, evaluate, and respond to a report made under section 26.719(b) to the NRC Operations Center Updated                                                                                  37.0        16.0      592.0          37.0        8.0  296.0      (296.0) regarding a significant FFD policy violation or programmatic failure 30-day report -- Review, evaluate, and respond to a report made under section 26.719(c) to the NRC detailing the Updated    investigation of any testing errors or unsatisfactory                         6.0          4.0        24.0          8.0        4.0    32.0        8.0 performance discovered at an LTF or HHS lab.
Table 5 Total            200.0                  3,107.0        186.0            1,872.0  (1,235.0)
                                                                                                                                                                -39.7%
Page 23 of 24


performance discovered at an LTF or HHS lab.                    6.0                4.0              24.0                  8.0              4.0        32.0 8.0 Table 5 Total                200.0        3,107.0              186.0    1,872.0      (1,235.0)
FINAL Supporting Statement, 10 CFR Part 26 Summary of Estimated Burden Hours and Costs (2017-2020)                               2014-2017  2017-2020 Annualized        Cost at    Annualized Annualized Change    Change Table            Description            Responses Burden Hours      $265/hour      Burden    Burden    Hours      %
-39.7%Page 23 of 24 FINAL Supporting Statement, 10 CFR Part 26 Summary of Estimated Burden Hours and Costs (2017-2020)2014-20172017-20201Recordkeeping (One-Time)-
1  Recordkeeping (One-Time)                   -           112.0 $         29,680       41.4     112.0     70.6   170.5%
112.0 $             29,680             41.4         112.0         70.6 170.5%2Recordkeeping (Annual)49.0 220,886.5 $     58,534,918   314,177.4  220,886.5 (93,290.9)-29.7%3Annual Reporting215.0 6,168.0 $       1,634,520       6,165.2     6,168.0           2.8 0.0%4Third Party Disclosure (Annual)     441,569.1         492,029.4 $    130,387,785   303,559.1  492,029.4 188,470.3 62.1%
2  Recordkeeping (Annual)                   49.0     220,886.5 $     58,534,918 314,177.4  220,886.5 (93,290.9) -29.7%
441,833.1           719,195.9 $    190,586,904   623,943.1  719,195.9   95,252.8 15.3%Tables 1 + 2 + 4 Burden >>>713,027.9 Records storage costs >>>75,580.95
3  Annual Reporting                        215.0       6,168.0 $     1,634,520   6,165.2   6,168.0       2.8     0.0%
$       5NRC Action186.0 1,872.0 $           496,080 Change%Annualized Burden Annualized Burden Change HoursTableDescription Annualized Burden Hours Cost at $265/hour Annualized Burden Hours Cost at $265/hour TOTAL ResponsesTableDescriptionActions Page 24 of 24}}
4  Third Party Disclosure (Annual)     441,569.1     492,029.4 $    130,387,785 303,559.1  492,029.4 188,470.3   62.1%
TOTAL      441,833.1     719,195.9 $    190,586,904 623,943.1  719,195.9 95,252.8     15.3%
Tables 1 + 2 + 4 Burden >>>     713,027.9 Records storage costs >>> $    75,580.95 Annualized        Cost at Table            Description              Actions Burden Hours      $265/hour 5  NRC Action                              186.0       1,872.0 $       496,080 Page 24 of 24}}

Revision as of 21:32, 29 October 2019

Part 26 - Burden Spreadsheet for Information Collection Renewal (3150-0146)
ML17236A380
Person / Time
Issue date: 08/24/2017
From:
Office of Nuclear Security and Incident Response, NRC/OCIO
To:
Shared Package
ML17236A377 List:
References
Download: ML17236A380 (24)
v • d • e


Text

FINAL Supporting Statement, 10 CFR Part 26 Description of Data Element Value Unit Data Source FFD Drug & Alcohol (D&A) Testing Programs 28 FFD program D&A testing programs 26 FFD program FFD program performance data (2015)

Reactor Construction Site D&A testing programs 2 FFD program Number of Sites covered by an FFD D&A Testing Program 69 site 2015 FFD program performance data Excludes DECON sites (Crystal River, Fort Calhoun, Kewaunee, San Operating Reactors 59 site Onofre, Vermont Yankee)

Reactors under Construction 2 site V.C. Summer (Units 2&3); Vogtle (Units 3&4)

Corporate Offices 5 site Duke, Exelon, Southern, TVA, and Xcel Fuel Cycle Facilities 2 site B&W, NFS Contractor/Vendor (C/V) 1 site INPO Drug Testing Laboratories Licensee Testing Facilities (LTFs) 6 LTF FFD program performance data (2015)

HHS-certified laboratories (HHS labs) 9 HHS lab Laboratory Testing 67 Number of sites using an LTF 6 LTF FFD program performance data (2015)

Number of sites only using an HHS-lab 61 HHS lab D&A Testing Program Data D&A Pgrm Construction Total Total Tests (all Reasons For Testing) 146,831 12,674 159,505 Pre-access 81,219 6,898 88,117 Random 57,476 4,653 62,128 FFD program performance data (average of 2013-2015)

For Cause 405 243 648 Post Event 480 375 855 Followup 7,250 505 7,756 Total Individuals with D&A testing violations (all Test Types) 826 253 1,079 Pre-access 568 147 715 Random 144 61 205 FFD program performance data (average of 2013-2015)

For Cause 56 32 88 Post Event 4 7 12 Followup 54 6 60 Total Testing violations (by results) D&A Pgrm Construction Total Number of drug & alcohol positive, adulterated, 826 253 1,079 substituted, and refusal to test results FFD program performance data (average of 2013-2015)

Number of drug only positive, adulterated, 621 217 838 substituted, and refusal to test results D&A Pgrm Construction Individuals subject to a random D&A testing program FFD program performance data (2013-2015) 103,933 7,634 Number of Reportable Events per Year (average 2013-2015) 2013 2014 2015 24-hour reports under 26.719(b) 37 report 26.719(b) hour event reports 40 38 33 30-day reports under 26.719(c) 8 report 26.719(c) day event reports 16 5 3 10 CFR 170.20 Average Cost per Professional Hour (2017) $265 hourly rate Previous clearance = $272/hour Fatigue management programs 21 program FFD program performance data (2015)

Page 1 of 24

FINAL Supporting Statement, 10 CFR Part 26 FFD program performance data (2012-2015) - 2012 data used in previous clearance; 2013-2015 used in current clearance Pre-Access Random For Cause Post-Event Followup Alcohol Total Results Average Results (2013-2015)

Tested Positive Tested Positive Tested Positive Tested Positive Tested Positive Total Tests Total + Totals without Alcohol All Sites 90,049 728 64,374 212 658 90 877 12 7,936 61 163,895 1,102 247 Construction sites 6,898 147 4,653 61 243 32 375 7 505 6 12,674 253 37 217 DECON sites 1,932 13 2,246 7 10 2 22 0 181 1 4,390 23 6 Sites w/o Construction & DECON 81,219 568 57,476 144 405 56 480 4 7,250 54 146,831 826 205 621 Results by Year Summary Results Pre-Access Random For Cause Post-Event Followup Alcohol Total Results 2015 Tested Positive Tested Positive Tested Positive Tested Positive Tested Positive Total Tests Total + Totals without Alcohol All Sites 88,593 790 64,755 225 654 106 1,016 17 8,380 60 163,398 1,198 248 Construction sites 6,395 130 6,179 86 276 49 535 13 703 9 14,088 287 35 DECON sites 2,014 16 1,556 5 4 1 18 0 108 1 3,700 23 4 Sites w/o Construction & DECON 80,184 644 57,020 134 374 56 463 4 7,569 50 145,610 888 209 679 Summary Results Pre-Access Random For Cause Post-Event Followup Alcohol Total Results 2014 Tested Positive Tested Positive Tested Positive Tested Positive Tested Positive Total Tests Total + Totals without Alcohol All Sites 92,368 762 64,689 221 694 83 897 13 7,942 54 166,590 1,133 255 Construction sites 8,414 191 4,957 63 266 33 392 7 510 1 14,539 295 46 DECON sites 1,243 4 1,994 11 10 4 16 0 154 0 3,417 19 8 Sites w/o Construction & DECON 82,711 567 57,738 147 418 46 489 6 7,278 53 148,634 819 201 618 Summary Results Pre-Access Random For Cause Post-Event Followup Alcohol Total Results 2013 Tested Positive Tested Positive Tested Positive Tested Positive Tested Positive Total Tests Total + Totals without Alcohol All Sites 89,187 631 63,678 190 627 80 718 5 7,487 69 161,697 975 238 Construction sites 5,886 120 2,822 34 186 15 197 2 303 7 9,394 178 29 DECON sites 2,538 19 3,187 6 17 0 32 0 280 2 6,054 27 5 Sites w/o Construction & DECON 80,763 492 57,669 150 424 65 489 3 6,904 60 146,249 770 204 566 Summary Results Pre-Access Random For Cause Post-Event Followup Alcohol Total Results 2012 Tested Positive Tested Positive Tested Positive Tested Positive Tested Positive Total Tests Total + Totals without Alcohol All Sites 101,438 765 67,943 205 724 86 883 7 8,147 50 179,135 1,113 255 Construction sites 4,675 102 2,819 31 237 14 157 2 276 4 8,164 153 25 DECON sites 2,873 12 3,402 8 30 3 24 0 372 2 6,701 25 7 Sites w/o Construction & DECON 93,890 651 61,722 166 457 69 702 5 7,499 44 164,270 935 223 712 Page 2 of 24

FINAL Supporting Statement, 10 CFR Part 26 FFD program performance data (2012-2015) - 2012 data used in previous clearance; 2013-2015 used in current clearance Average Average Population Subject to Random Testing 2012 2013 2014 2015 2013-2015 All Sites 123,278 115,532 115,709 115,254 115,498 All sites (w/o Construction & DECON) 112,732 104,728 104,037 103,033 103,933 CONSTRUCTION V.C. Summer Units 2 and 3 1,642 1,950 3,064 3,802 Vogtle Units 3 and 4 2,736 3,099 5,037 5,950 4,378 5,049 8,101 9,752 7,634 DECOMMISSIONING Crystal River 1,544 922 592 392 Fort Calhoun 1,441 1,204 1,184 Kewaunee 829 495 295 205 San Onofre 2,934 1,899 723 688 Vermont Yankee 861 998 757 0 << Is not reporting data since ceasing operations at the end of 2014 Total 6,168 5,755 3,571 2,469 3,932 Alcohol Positive Results 2012 2013 2014 2015 Total All Sites 255 238 255 248 Total All Sites w/o Construction & DECON 223 204 201 209 CONSTRUCTION V.C. Summer Units 2 and 3 10 18 21 18 Vogtle Units 3 and 4 15 11 25 17 Total 25 29 46 35 DECOMMISSIONING Crystal River 0 0 3 0 Fort Calhoun 0 3 1 4 Kewaunee 2 0 2 0 San Onofre 1 0 0 0 Vermont Yankee 4 2 2 0 Total 7 5 8 4 HHS-Certified Labs Performing Testing for Part 26 Licensees & Other Entities 2014 OMB Clearance (used 2012 FFD program performance data) 2017 OMB Clearance (used 2015 FFD program performance data) 1 Alere Toxicology 1 Alere Toxicology (Gretna, LA) 2 Clinical Reference Lab (Lenexa, KS) 2 Clinical Reference Lab (Lenexa, KS) 3 Drug Scan (Horsham, PA) 3 Drug Scan (Horsham, PA) 4 Laboratory Corporation of America (RTP, NC) 4 Laboratory Corporation of America (RTP, NC) 5 Laboratory Corporation of America 5 MedTox Laboratories (St. Paul, MN) 6 MedTox Laboratories (St. Paul, MN) 6 Quest Diagnostics (Lenexa, KS) 7 Quest Diagnostics (Lenexa, KS) 7 Quest Diagnostics (Norristown, PA) 8 Quest Diagnostics (Norristown, PA) 8 Quest Diagnostics (Atlanta, GA) 9 Quest Diagnostics (Tucker, GA) 9 Southwest Laboratories (Phoenix, AZ) 10 Quest Diagnostics (Atlanta, GA) 11 Southwest Laboratories (Phoenix, AZ) 12 not specified in hardcopy report Page 3 of 24

FINAL Supporting Statement, 10 CFR Part 26 Approved Clearance Values Extension Table 1: One Time Recordkeeping (approved 11/30/14 - ICR 201407-3150-007) (2017-2020)

Index Key: Burden

- Updated Estimate Number of Burden Hrs Total Number of Burden Hrs Total

- Duplicative Section Record- per Recordkeeper Burden Hrs Record- per Recordkeeper Burden Hrs Change

- Moved

- New keepers (Annualized) (Annualized) keepers (Annualized) (Annualized)

- Removed Updated 26.27(a): Develop FFD policy statement 0 107.0 - 0 112.0 - -

Updated 26.27(a): Develop FFD procedures 0 213.0 - 0 212.0 - -

Updated 26.29(a) and (b): Develop FFD training course and exam 0 96.3 - 0 100.0 - -

Moved 26.29(b): All current staff take FFD exam and FFD exam Moved to Table 4 0 400.4 - -

(to Table 4) graded (Third-Party Disclosure Burden)

Moved Moved to Table 4 26.29(c)(2): FFD training for current staff 0 4,710.7 - -

(to Table 4) (Third-Party Disclosure Burden) 26.31(b)(1)(v): Develop behavioral observation program Updated Burden accounted for under 26.27 (0 programs) Burden accounted for under 26.27(a) -

(BOP) procedures 26.31(d)(1)(i)(C): Develop rigorous testing procedures to ensure that the MRO can evaluate the use of substances NEW Not included in previous clearance Burden accounted for under 26.27(a) not included in the NRC-required testing panel (if additional substance testing is performed) 26.31(d)(1)(i)(D) and (d)(1)(ii): Documentation of forensic Moved toxicologist review and certification of additional drug(s) to Previously accounted for in Table 2 3.0 5.3 16.0 16.0 (from Table 2) be included in the licensee or other entity's drug testing as Annualized Burden panel Duplicative Burden accounted for in section 26.31(d)(1)(iii): Document additional drugs in testing panel 0 0.3 - -

Burden 26.31(d)(3)(iii)(A) and (d)(3)(iii)(C) 26.31(d)(3)(iii)(A) and (d)(3)(iii)(C): Documentation of Moved forensic toxicologist review and certification of lower drug Previously accounted for in Table 2 3.0 5.3 16.0 16.0 (from Table 2) testing cutoff levels than specified by Part 26, and as Annualized Burden inclusion of cutoff levels in the FFD policy and procedures 26.37(a): Develop a system of files and procedures to Updated 0 2.7 - 0 24.0 - -

protect personal information collected under Part 26 REMOVED REMOVED 26.37(b): Obtain signed consent for release of information 0 98.1 - -

[covered by Table 2 - 26.37(b)]

26.39(a) and (b): Develop procedures for the review of a Updated 0 13.3 - 0 120.0 - -

determination that an individual has violated the FFD policy Updated 26.85(a): Develop urine collector qualification training 0 5.3 - 0 13.3 - -

Updated 26.85(b): Develop alcohol collector qualification training 0 5.3 - 0 5.3 - -

26.127(a) - (e): Develop LTF procedures for specimen handling and chain-of-custody, assays performed, Updated 0 80.0 - 0 80.0 - -

instrument and test setup, and remedial actions for systems and testing devices 26.137(a): Develop LTF procedures for quality assurance/

Updated 0 13.3 - 0 13.3 - -

quality control (QA/QC) program Moved 26.153(e): Record of pre-award inspection of new HHS lab Previously accounted for in Table 2 3.0 13.3 40.0 40.0 (from Table 2) (completed prior to awarding contract for testing services) as Annualized Burden 26.153(f): Record that Part 26 specified requirements Moved Previously accounted for in Table 2 included in a licensee's or other entity's contract with a new 3.0 13.3 40.0 40.0 (from Table 2) as Annualized Burden HHS lab 26.155(a)(1), (a)(3) - (a)(5); (b),(c), (e), and (f):

Confirm HHS lab personnel qualifications and procedures Updated 0 2.7 - Burden accounted for under 26.153(e) -

place pursuant to HHS laboratory certification also meet Part 26 requirements (new HHS lab) 26.157(a) - (e): Confirm HHS lab procedures in place for accession, receipt, shipment, and testing of specimens Updated 0 2.7 - Burden accounted for under 26.153(e) -

pursuant to HHS laboratory certification also meet Part 26 requirements (new HHS lab) 26.159(a), (c), (e), (f): Confirm HHS lab procedures for specimen security, chain of custody, and preservation in Updated place pursuant to HHS laboratory certification 0 2.7 - Burden accounted for under 26.153(e) -

requirements also meet Part 26 requirements (new HHS lab) 26.203(a): Prepare fatigue management policy (In addition 2.0 7.3 14.6 0 7.3 - (14.6) to 26.27 burden) 26.203(b): Prepare fatigue management procedures (in 2.0 1.7 3.4 0 1.7 - (3.4) addition to 26.27 burden) 26.203(c): Prepare training on fatigue management. 2.0 2.0 4.0 0 2.0 - (4.0) 26.205(b): Develop work hour tracking system 2.0 7.7 15.4 0 7.7 - (15.4) 26.205(c): Develop individual work scheduling system 2.0 2.0 4.0 0 2.0 - (4.0) 26.401(b): Prepare a reactor construction site D&A testing Burden accounted for under Updated 0 60.0 - -

program plan section 26.403(a) and (b) 26.403(a): Develop FFD policy statement Updated 0 107.0 - 0 112.0 - -

(reactor construction site D&A testing program)

Moved 26.403(a): Distribute FFD policy statement to subject 0 5.0 - Moved to Table 2 -

(to Table 2) individuals (reactor construction site D&A testing program) 26.403(b): Develop written FFD procedures Updated 0 213.0 - 0 216.0 - -

(reactor construction site D&A testing program)

Moved 26.405(d): Record of testing for specified drugs, Previously accounted for in Table 2 Burden accounted for under section 26.403(a) -

(from Table 2) adulterants, and alcohol, at Part 26 specified cutoff levels as Annualized Burden 26.405(e): Develop specimen collection and D&A testing procedures to protect the donor's privacy, integrity of the Previously accounted for in Table 2 NEW Burden accounted for under section 26.403(b) specimen, and stringent quality controls to ensure accurate as Annualized Burden test results Page 4 of 24

FINAL Supporting Statement, 10 CFR Part 26 Approved Clearance Values Extension Table 1: One Time Recordkeeping (approved 11/30/14 - ICR 201407-3150-007) (2017-2020)

Index Key: Burden

- Updated Estimate Number of Burden Hrs Total Number of Burden Hrs Total

- Duplicative Section Record- per Recordkeeper Burden Hrs Record- per Recordkeeper Burden Hrs Change

- Moved

- New keepers (Annualized) (Annualized) keepers (Annualized) (Annualized)

- Removed 26.406(a), (b), and (d): Develop a fitness monitoring Updated program (applies if reactor construction site D&A testing 0 26.7 - 0 40.0 - -

program does not conduct random testing) 26.406(c): Develop procedures for fitness monitors Updated (applies if reactor construction site D&A testing program 0 40.0 - 0 40.0 - -

does not conduct random testing) 26.407: Develop procedures for behavioral observation Updated 0 40.0 - 0 40.0 - -

(reactor construction site D&A testing program) 26.411(a): Develop procedures for maintaining a system of NEW files to protect personal information collected under Not included in previous clearance 0 40.0 -

Subpart K of Part 26 26.413: Develop procedures for the review of a Updated determination that an individual violated the FFD policy 0 120.0 - 0 120.0 - -

(reactor construction site D&A testing program) 26.713(g): Documentation on testing for additional drugs Burden accounted for under Moved as permitted under section 26.31(d)(1), use of more Previously accounted for in Table 2 section 26.31(d)(1)(i)(D) and (d)(1)(ii), and (from Table 2) stringent testing cutoff levels as permitted under section as Annualized Burden section 26.31(d)(3)(iii)(A) and (d)(3)(iii)(c) 26.31(d)(3), or both.

Table 1: Total 41.4 112.0 70.6 Page 5 of 24

Final Supporting Statement, 10 CFR Part 26 Approved Clearance Values Extension Table 2: Annual Recordkeeping (approved 11/30/14 - ICR 201407-3150- (2017-2020)

Index Key:

Burden

- New Total Burden Total Number of Burden Number of Estimate

- Updated Annual Hours per Annual Section Record- Hours per Record- Change

- Moved Burden Record- Burden keepers Recordkeeper keepers

- Duplicative Hours keeper Hours

- Removed 26.4(j):For personnel granted authorization by a licensee, who are covered by the D&A testing program regulated by a State or Federal agency - (1) record of training that Updated 30.5 2.0 61.0 33.5 2.0 67.0 6.0 demonstrates section 26.29(a) training requirements met (if not already covered by the program); (2) record of notice of any FFD policy violation 26.27(b): Make FFD policy statement readily available to Updated 28.0 4.0 112.0 26.0 16.0 416.0 304.0 subject personnel Updated 26.27(c): Updates to FFD policy and procedures 28.0 8.0 224.0 26.0 80.0 2,080.0 1,856.0 26.27(d): Provide FFD policy and procedures to NRC for Updated 28.0 4.0 112.0 26.0 4.0 104.0 (8.0) review (performed during periodic inspections) 26.29(b): Record of training completion (initial training on Updated 28.0 2.0 56.0 26.0 104.1 2,707.3 2,651.3 FFD policy) and results of comprehensive examination 26.29(c)(2): Record of training completion (annual refresher Updated 28.0 2.0 56.0 26.0 133.2 3,464.4 3,408.4 training on FFD policy) 26.29(d): Record acceptance of FFD training from other 28.0 4.0 112.0 26.0 4.0 104.0 (8.0) licensees' programs 26.31(b)(1)(i): Records of background investigations, credit and criminal history checks, and psychological assessments Updated 28.0 17.5 490.0 26.0 16.0 416.0 (74.0) of checks for performed on individuals designated as FFD personnel Duplicative 26.31(b)(1)(v): Record results of behavioral observation for Burden accounted for under 28.0 80.0 2,240.0 (2,240.0)

Burden FFD program personnel section 26.189(c) 26.31(d)(1)(i)(D): Document analysis and certification for Moved testing of drugs not included in the NRC minimum testing 2.3 4.0 9.2 Moved to Table 1 (9.2)

(to Table 1) panel Moved 26.31(d)(2)(ii): Document licensee additions to tested drugs 2.3 8.0 18.4 Moved to Table 1 (18.4)

(to Table 1) 26.31(d)(3)(ii): Document LTF technician qualifications to Burden accounted for under NEW Not included in clearance perform validity and drug tests. section 26.125(b) and (c)

Moved 26.31(d)(3)(iii)(A): Document more stringent cutoff levels 2.0 8.0 16.0 Moved to Table 1 (16.0)

(to Table 1)

Moved 26.31(d)(3)(iii)(C): Document evaluation and certification of 2.0 8.0 16.0 Moved to Table 1 (16.0)

(to Table 1) more stringent cutoff levels Removed.

26.31(d)(6): Donor provides written permission to conduct This is a testing limitation provision and REMOVED - 1.0 - -

another analysis or test on a specimen does not have a corresponding recordkeeping or reporting burden.

Duplicative Burden accounted for under 26.33: Behavioral observation records 28.0 400.0 11,200.0 (11,200.0)

Burden section 26.189(c)

Moved 26.35(a): Employee assistance program (EAP) records 28.0 16.0 448.0 Moved to Table 4 (448.0)

(to Table 4) 26.35(c): Record of written waiver of right to privacy from Updated 28.0 2.0 56.0 13.0 2.0 26.0 (30.0) individuals given to the Employee Assistance Program (EAP) 26.35(c): Record of EAP disclosure to a licensee or other Updated entity that an individual poses an immediate hazard, or who 14.0 1.0 14.0 13.0 1.0 13.0 (1.0) has waived in writing the right to privacy 26.37(b)(1): Record of signed consent from individual to Updated disclose information collected under Part 26 to the 28.0 40.0 1,120.0 26.0 2.5 64.5 (1,055.5) individuals representative on an FFD matter 26.37(c): Record of signed release from subject individual to Updated disclose personal information collected under Part 26 to other 28.0 40.0 1,120.0 26.0 40.0 1,040.0 (80.0) licensees or other entities 26.37(d): FFD management provides records to individual on Updated 28.0 40.0 1,120.0 26.0 40.0 1,040.0 (80.0) an FFD violation Duplicative 26.39(a): Maintain procedures for the review of FFD violation Burden accounted for under 28.0 40.0 1,120.0 (1,120.0)

Burden determinations section 26.27(c) 26.39(b): D&A testing program provides notice to an NEW individual of the grounds of an FFD policy violation Not included in clearance 26.0 87.3 2,270.6 2,270.6 determination and review procedures 26.39(d): If a review of an FFD violation finds in favor of the Updated individual, the licensee or other entity updates records (delete 28.0 40.0 1,120.0 6.0 16.0 96.0 (1,024.0) or correct information found to be inaccurate) 26.39(e): C/V with a D&A testing program provides review Updated - 0.5 - 1.0 0.5 0.5 0.5 procedures to each individual that has violated the FFD policy Burden accounted for under Burden accounted for under 26.41(a), (b), and (c): Record of audits -

section 26.41(f) section 26.41(f) and (g) 26.41(d): Record of review of C/V audit results 28.0 40.0 1,120.0 26.0 40.0 1,040.0 (80.0) 26.41(f): Document and report audit results 28.0 40.0 1,120.0 26.0 40.0 1,040.0 (80.0)

Page 6 of 24

Final Supporting Statement, 10 CFR Part 26 Approved Clearance Values Extension Table 2: Annual Recordkeeping (approved 11/30/14 - ICR 201407-3150- (2017-2020)

Index Key:

Burden

- New Total Burden Total Number of Burden Number of Estimate

- Updated Annual Hours per Annual Section Record- Hours per Record- Change

- Moved Burden Record- Burden keepers Recordkeeper keepers

- Duplicative Hours keeper Hours

- Removed 26.41(g): Sharing of audit reports - D&A testing programs may jointly conduct audits or accept audits of C/Vs and HHS Updated 28.0 40.0 1,120.0 26.0 40.0 1,040.0 (80.0) labs conducted by other D&A testing programs (if the audit addresses the same services utilized by each program) 26.53(e)(2): Record that C/Vs informed licensee of the denial Updated 1.0 120.0 120.0 1.0 13.0 13.0 (107.0) or termination of an individual's authorization 26.53(g): Record that CVs and other licensees informed of 7.0 8.0 56.0 0 8.0 - (56.0)

Part 26 violations 26.53(h): Obtain and retain written consent from each Updated individual before initiating any actions under Subpart C of 28.0 1,677.0 46,956.0 26.0 156.2 4,061.0 (42,895.0)

Part 26 26.53(i): Individual applying for authorization is informed in Updated writing of the reason(s) for denial or termination of 28.0 23.3 652.4 26.0 21.8 567.7 (84.7) authorization 26.55(a)(1) - (a)(2): Initial authorization 26.57(a)(1) - (a)(2): Authorization update Burden accounted for under sections 26.59(a)(1) - (a)(2): Authorization reinstatement Burden accounted for under Updated 26.61(a), (a)(1), and (a)(2), -

For each individual applying for authorization, a record of a sections 26.61 and 26.63 and 26.63 (a), (c), and (e) completed self-disclosure, employment history, and suitable inquiry is maintained 26.59(c)(1): Obtain, review, and retain an applicants self- Burden accounted for under Burden accounted for under Updated -

disclosure section 26.61 section 26.61(a), (a)(1) and (a)(2) 26.61(a), (a)(1), and (a)(2): Obtain, review, and retain an Updated 28.0 1,197.0 33,516.0 26.0 1,561.9 40,609.7 7,093.7 applicants written self-disclosure and employment history 26.61(b) and (c): Specify the information to be collected in Burden accounted for under NEW Not included in clearance the self-disclosure and employment history section 26.61(a), (a)(1) and (a)(2) 26.63(a), (c), and (e): Obtain, review, and retain an Updated 28.0 1,197.0 33,516.0 26.0 1,561.9 40,609.7 7,093.7 applicants suitable inquiry 26.63(c)(2): Obtain, review, and retain information on an Updated 28.0 4.0 112.0 26.0 4.0 104.0 (8.0) applicants U.S. military service (i.e., form DD 214) 26.63(c)(3): Document inability to obtain information from an Updated 28.0 2.7 75.6 26.0 3.0 78.0 2.4 applicants past employer(s) 26.63(d) and (e): Maintain documentation of denial or unfavorable termination of authorization from other FFD 28.0 1.0 28.0 26.0 1.0 26.0 (2.0) programs 26.63(f): Specifies the time periods that a suitable inquiry Burden accounted for under NEW must cover (for initial authorization, authorization update, and Not included in clearance section 26.63(a), (c) and (e) authorization reinstatement) 26.65(d) and (e): Record of reinstatement or administrative 28.0 4.0 112.0 26.0 4.0 104.0 (8.0) withdrawal of authorization 26.65(f): Authorization reinstatement after an interruption --

Updated record of administrative withdrawal of authorization under 28.0 1.0 28.0 26.0 1.0 26.0 (2.0) section 26.65(d)(1)(ii) or (e)(2)(iii)(B) 26.67 Record of random D&A testing of persons who have Duplicative Burden accounted for under section applied for authorization and who have received a pre-access 28.0 5.5 154.0 (154.0)

Burden 26.183(d)(2)(i) test, but who have yet to be granted authorization 26.69(b) and (c)(1): Authorization following a 1st or 2nd positive drug or alcohol test result, or if other PDI is identified Burden accounted for under Burden accounted for under Updated -

-- obtain, review, and retain an applicants self-disclosure and section 26.713(a)(1) section 26.61(a) employment history 26.69(c)(2): Record that the licensee or other entity identified Updated and resolved PDI (not reviewed and favorably resolved by a 28.0 40.0 1,120.0 26.0 62.5 1,624.4 504.4 previous licensee or other entity) 26.69(c)(3): Record that the licensee or other entity verified that an applicant with a prior FFD testing violation (i.e., a 5- Burden accounted for under Updated 28.0 40.0 1,120.0 (1,120.0) year denial for a 2nd positive result) has abstained from section 26.69(c)(4) substance abuse for at least 5 years 26.69(c)(4): Record that an SAE conducted a determination of fitness and concluded that an applicant with PDI is fit to safely and competently perform duties (i.e., evaluated clinically appropriate treatment and followup testing plans were developed by an SAE -- for an applicant with a prior 1st Updated 28.0 3.0 84.0 26.0 40.0 1,040.0 956.0 positive result; ensured treatment recommendations and followup testing from an SAEs determination of fitness are initiated -- for an applicant with a prior 2nd positive result; or verified the applicant is in compliance with and successfully completed any followup testing and treatment plans) 26.69(c)(5): Record of negative results for pre-access D&A Updated 28.0 1.0 28.0 26.0 52.1 1,353.7 1,325.7 testing (needed prior to granting authorization) 26.69(d): Record of reviewing officials determination on an Updated 28.0 24.0 672.0 26.0 24.0 624.0 (48.0) applicants request for access authorization Page 7 of 24

Final Supporting Statement, 10 CFR Part 26 Approved Clearance Values Extension Table 2: Annual Recordkeeping (approved 11/30/14 - ICR 201407-3150- (2017-2020)

Index Key:

Burden

- New Total Burden Total Number of Burden Number of Estimate

- Updated Annual Hours per Annual Section Record- Hours per Record- Change

- Moved Burden Record- Burden keepers Recordkeeper keepers

- Duplicative Hours keeper Hours

- Removed 26.69(e): Record that follow-up testing and treatment plan for an applicant from the D&A testing program of another Updated 28.0 8.0 224.0 26.0 8.0 208.0 (16.0) licensee or other entity has been verified (that is treatment and follow-up testing successfully completed) 26.69(e)(1): Record that information transmitted on testing Updated and treatment plans to other FFD programs (at donor 28.0 8.0 224.0 26.0 8.0 208.0 (16.0) request) 26.75(a) - (e), and (g): Records of sanctions for FFD Burden accounted for under Consolidated 28.0 12.0 336.0 (336.0) violations section 26.39(b) 26.75(h): Record that an individuals authorization was administratively withdrawn due to impairment confirmed Updated 28.0 18.0 504.0 26.0 15.6 405.3 (98.7) under section 26.189, or because the individual posed a safety hazard 26.75(i): Record of temporary administrative withdrawal of an Updated individual's authorization due to an initial positive test result 28.0 80.0 2,240.0 0 80.0 - (2,240.0) for marijuana and/or cocaine at an LTF 26.75(i)(3): Eliminate from an individuals record any references to a temporary administrative withdrawal of Updated authorization due to an initial positive marijuana and/or 28.0 1.0 28.0 0 1.0 - (28.0) cocaine test result at an LTF that did not confirm positive after testing at an HHS lab 26.85(a) and (b): Training of urine and alcohol collectors and Updated 28.0 8.0 224.0 26.0 8.0 208.0 (16.0) maintain training records in personnel files 26.87(d)(3): If a collection site cannot be dedicated solely to collecting specimens, secure the portion of the facility when a Updated 28.0 1.0 28.0 26.0 1.0 26.0 (2.0) specimen collection is in process and post a sign indicating access permitted only to authorized personnel 26.87(f)(1) and (f)(3) - (f)(5): Post a sign outside the collection area (if a public restroom used) and document on the custody-and-control form (CCF) the name of a same Updated gender observer (in the exceptional event that a designated 28.0 2.0 56.0 2.0 0.5 1.0 (55.0) collection site is inaccessible, the collector is not the same gender as the donor and a urine specimen must be immediately collected) 26.89(a): Collector notifies FFD management that a donor Updated 28.0 1.0 28.0 4.0 0.25 1.0 (27.0) failed to report to the collection site 26.89(b)(1), (b)(2), and (b)(4): Record that ID and consent-to-28.0 1.5 42.0 26.0 1.5 39.0 (3.0) testing form obtained 26.89(b)(3): Record that FFD management informed that an Updated 28.0 1.0 28.0 26.0 1.0 26.0 (2.0) individual did not present identification (pre-access testing) 26.89(c): Collector documents on CCF a donor's refusal to Burden accounted for under section Consolidated 28.0 1.0 28.0 (28.0) cooperate with the collection process 26.107(b) 26.91(c)(1) - (c)(3): Record of evidential breath testing (EBT) Burden accounted for under section Burden accounted for under section Updated -

device test results 26.715(b)(2) 26.715(b)(2) 26.91(e)(4): Record that results cancelled after EBT

- 6.0 - 0 6.0 - -

calibration check failure Updated 26.91(e)(5): EBT maintenance records 28.0 6.0 168.0 26.0 6.0 156.0 (12.0) 26.93(a)(6): Document that alcohol pre-test questions Updated 28.0 80.0 2,240.0 26.0 47.1 1,223.6 (1,016.4) communicated to the donor 26.95(b)(5): Record donor identity for initial alcohol breath 28.0 80.0 2,240.0 26.0 47.1 1,223.6 (1,016.4) test Updated 26.97(b)(2): Record reason for new oral fluid alcohol test - 5.0 - 0 0.25 - -

26.97(c)(1): Document reason for failure of 2nd collection Updated - 2.5 - 0 0.25 - -

attempt 26.97(d): Record results and alcohol screening device used - 0.25 - 0 0.25 - -

26.99(b): Record time of initial alcohol test of 0.02 percent or Burden accounted for under section Burden accounted for under section Updated -

higher blood alcohol concentration (BAC) 26.715(b)(2) 26.715(b)(2)

Duplicative 26.101(b)(7): Record time and BAC result of confirmatory Burden accounted for under section

- - - -

Burden alcohol test 26.715(b)(2) 26.103(b): Record that FFD management notified of a Updated 8.0 0.25 2.0 8.0 0.25 2.0 -

confirmatory alcohol test result of 0.01 to 0.02 percent BAC 26.107(b): Collector documents on CCF any donor conduct Updated during collection process indicating an attempt to tamper with 28.0 0.1 2.8 26.0 0.25 6.5 3.7 a specimen, and notifies FFD management 26.109(b)(3): Collector documents on CCF that the donor Updated was unable to provide a specimen in the 3-hour time allotted 28.0 0.5 14.0 26.0 0.25 6.5 (7.5)

(i.e., a shy bladder), and notifies FFD management Page 8 of 24

Final Supporting Statement, 10 CFR Part 26 Approved Clearance Values Extension Table 2: Annual Recordkeeping (approved 11/30/14 - ICR 201407-3150- (2017-2020)

Index Key:

Burden

- New Total Burden Total Number of Burden Number of Estimate

- Updated Annual Hours per Annual Section Record- Hours per Record- Change

- Moved Burden Record- Burden keepers Recordkeeper keepers

- Duplicative Hours keeper Hours

- Removed 26.109(b)(4): Collector documents on CCF if a specimen (less than 30 mL) appears to be tampered with and/or donor Burden accounted for under section Consolidated 28.0 0.3 8.4 (8.4) behavior during collection indicated a possible subversion 26.107(b) attempt, and notifies FFD management 26.111(b): Collector documents on CCF if specimen Burden accounted for under section Consolidated characteristics (color, clarity) indicate possible tampering by 4.0 0.3 1.0 (1.0) 26.107(b) the donor 26.111(c): Collector documents on CCF unusual specimen Burden accounted for under section Consolidated temperature and/or observations during the collection 28.0 0.3 8.4 (8.4) 26.107(b) indicating possible tampering, and notifies FFD management.

26.113(b)(3): Collector completes CCF for split-specimen Burden accounted for under Updated 28.0 0.3 8.4 (8.4) collection section 26.117(c) - (e) 26.115(b): Collector documents on CCF approval from FFD Updated manager or MRO to collect a specimen under direct 28.0 0.5 14.0 26.0 0.5 13.0 (1.0) observation Duplicative 26.115(d): Collector documents on CCF that observed Burden accounted for under 28.0 0.3 8.4 (8.4)

Burden collection performed and reason for the observed collection section 26.115(b)

Duplicative 26.115(f)(3): Collector documents on CCF the name of Burden accounted for under 28.0 0.3 8.4 (8.4)

Burden observer of directly observed collection section 26.115(b) 26.117(c) - (e): Collector prepares ID labels and CCF forms Updated 28.0 60.0 1,680.0 26.0 188.2 4,894.4 3,214.4 for specimen shipment 26.119(a), (e), and (f): Written evaluation from the physician who performed a medical evaluation of a donor with a shy Updated 28.0 6.0 168.0 13.0 2.0 26.0 (142.0) bladder (i.e., unable to provide a specimen of adequate volume in the allotted 3-hours) 26.119(b): Record that MRO provided information and Updated instructions to the physician who is to perform the 28.0 2.0 56.0 13.0 1.0 13.0 (43.0) examination of a donor with a shy bladder 26.125(b) and (c): Records on the proficiency and Updated 7.0 16.0 112.0 6.0 16.0 96.0 (16.0) qualifications of LTF personnel 26.127 (a) - (e): Maintain LTF written procedures on the handling of specimens, chain-of-custody procedures, testing Updated 7.0 200.0 1,400.0 6.0 40.0 240.0 (1,160.0) assays, instrument and device setup, and remedial actions for systems and testing devices.

26.129(a): Maintain documentation of access to secure areas Updated 7.0 2.5 17.5 6.0 4.0 24.0 6.5 of an LTF by all authorized individuals (i.e., an access log) 26.129(b): LTF inspects specimen packages, CCFs, and Updated obtains memorandum from specimen collectors to correct 7.0 0.5 3.5 6.0 0.5 3.0 (0.5) identified discrepancies 26.129(b)(1): LTF record of report to senior licensee or other Updated entity management of attempts to tamper with specimens in 7.0 1.0 7.0 0 1.0 - (7.0) transit 26.129(d): LTF procedures for tracking CCF of specimens 7.0 80.0 560.0 6.0 80.0 480.0 (80.0) 26.135(b): LTF record of direction from MRO to send Bottle Updated 7.0 2.2 15.4 6.0 0.5 3.0 (12.4)

B of a split specimen to a second HHS lab for testing 26.137(a): Record of a QA/QC program and procedures for 7.0 4.0 28.0 6.0 4.0 24.0 (4.0)

LTF 26.137(b)(1)(ii): LTF documentation of performance testing Updated of a device not approved by SAMHSA for point-of-collection 2.0 40.0 80.0 0 40.0 - (80.0) testing 26.137(b)(1)(iii): LTF documentation of annual test results for Updated a device not approved by SAMHSA for point-of-collection 2.0 20.0 40.0 0 20.0 - (40.0) testing 26.137(b)(3): LTF records submitting 1 in 10 specimens that Updated test negative on validity screening testing are sent to an HHS 7.0 40.0 280.0 0 40.0 - (280.0) lab as part of the LTF's QA program 26.137(d)(6): LTF records that 1 in 10 specimens that test NEW negative on initial validity testing are sent to an HHS lab for Not included in clearance 6.0 40.0 240.0 240.0 testing as part of the LTFs QA program Duplicative 26.137(e)(7): LTF documented procedures to protect against Burden accounted for under 7.0 2.0 14.0 (14.0)

Burden carryover material section 26.127 (a) - (e)

Updated 26.137(f)(5): LTF records on testing errors 7.0 24.0 168.0 6.0 8.0 48.0 (120.0)

Updated 26.137(h): LTF labeling of standards and controls 7.0 65.0 455.0 6.0 40.0 240.0 (215.0) 26.139(d): Record that the LTF prepared a summary of test Updated results for inclusion in the FFD annual program performance 7.0 40.0 280.0 6.0 40.0 240.0 (40.0) report submitted under section 26.717 Moved 26.153(e): Record of pre-award inspection of new HHS lab 28.0 40.0 1,120.0 Moved to Table 1 (1,120.0)

(to Table 1) (completed prior to awarding contract for testing services)

Moved 26.153(f): Records that Part 26 specified requirements 28.0 40.0 1,120.0 Moved to Table 1 (1,120.0)

(to Table 1) included in contract with HHS lab Page 9 of 24

Final Supporting Statement, 10 CFR Part 26 Approved Clearance Values Extension Table 2: Annual Recordkeeping (approved 11/30/14 - ICR 201407-3150- (2017-2020)

Index Key:

Burden

- New Total Burden Total Number of Burden Number of Estimate

- Updated Annual Hours per Annual Section Record- Hours per Record- Change

- Moved Burden Record- Burden keepers Recordkeeper keepers

- Duplicative Hours keeper Hours

- Removed 26.153(g): Record of memorandum sent to the HHS lab Updated 28.0 0.5 14.0 26.0 0.5 13.0 (1.0) explaining use of non-federal CCF form 26.159(b)(1): Record that the licensee or other entity Updated received noticed from an HHS lab within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of the lab 28.0 1.0 28.0 0 1.0 - (28.0) identifying evidence of tampering with specimen.

26.159(i): Record of written authorization to store specimens 28.0 0.5 14.0 26.0 0.5 13.0 (1.0) other than 1 year Duplicative 26.163(a)(2): Record that special analyses testing conducted Burden accounted for under section 28.0 1.0 28.0 (28.0)

Burden on a dilute specimen and report of the test results 26.169(c)(1) 26.165(b)(1): Record of a donor request for the retesting of Duplicative Burden accounted for under section an aliquot of a single specimen or the testing of the Bottle B 28.0 1.0 28.0 (28.0)

Burden 26.165(b)(6) split specimen at a second HHS lab 26.165(b)(2): Record that MRO informed the donor of the Duplicative opportunity to request the retesting of an aliquot of a single Burden accounted for under section 28.0 0.5 14.0 (14.0)

Burden specimen or the testing of the Bottle B split specimen at a 26.185(c) second HHS lab 26.165(b)(3): Donor's written permission provided to the MRO for the retesting of an aliquot of a single specimen or Burden accounted for under section Burden accounted for under section Updated -

the testing of the Bottle B split specimen at a second HHS 26.165(b)(1) 26.165(b)(6) lab 26.165(b)(4): Record that the donor presented Duplicative Burden accounted for under section documentation to the MRO on the inability to submit a timely 6.0 0.2 1.2 (1.2)

Burden 26.185(c) request to initiate specimen retesting at a second HHS lab 26.165(b)(6): MRO reviews HHS lab results on the retesting of an aliquot of a single specimen or testing of the Bottle B Updated 28.0 3.0 84.0 26.0 1.2 31.1 (53.0) split specimen, informs the donor of the results, and notified FFD management 26.165(c)(4): Results report received from the second HHS Burden accounted for under Updated lab that performed retesting an aliquot of a single specimen 12.0 2.5 30.0 (30.0) section 26.165(b)(6) or the testing of the Bottle B split specimen 26.165(f)(1): Adjustments to personnel files and written notifications regarding the results of retesting an aliquot of a Updated 28.0 6.0 168.0 0 6.0 - (168.0) single specimen or testing of the Bottle B split specimen, including temporary administrative action 26.165(f)(1)(iv) and (f)(2): Written record and notice that Updated records purged of references to temporary administrative 28.0 8.0 224.0 0 8.0 - (224.0) action 26.167(f)(3): Record received from the Responsible Person of an HHS lab on a false positive BPTS testing error (determined to be technical or methodological),

Updated demonstrating that retesting of all positive, adulterated, 12.0 1.0 12.0 0 1.0 - (12.0) substituted, and invalid specimens from the time of final resolution of the error back to the time of the last satisfactory performance test cycle has been completed 26.168(a) Maintain documentation of HHS lab certification of NEW Not included in clearance 26.0 2.6 67.0 67.0 BPTS formulation 26.168(i)(2): Licensee or other entity completes CCF for a Moved BPTS, places fictional initials on specimen labels, and Moved from Table 4 26.0 34.4 893.3 893.3 (from Table 4) indicates on the MRO copy of the CCF that the specimen is a BPTS 26.169(a): Records of reports of test results from the HHS Burden covered under Burden accounted for under Updated -

lab section 26.169(c)(1) through (c)(5) section 26.183(c)(1) 26.169(c)(1): Records of HHS lab reports of positive, Duplicative Burden accounted for under adulterated, substituted, dilute, and invalid test results 12.0 80.0 960.0 (960.0)

Burden section 26.183(c)(1) received by the MRO 26.169(c)(2): Records of HHS lab reports of the numerical Duplicative Burden accounted for under values of all positive drug test results (i.e., quantitative test 12.0 1.0 12.0 (12.0)

Burden section 26.183(c)(1) results requested by MRO)

Duplicative 26.169(c)(2): Records of HHS lab reports of quantitative test Burden accounted for under 12.0 0.5 6.0 (6.0)

Burden results for opiates section 26.183(c)(1)

Duplicative 26.169(c)(3): Records of HHS lab reports of quantitative test Burden accounted for under 12.0 2.5 30.0 (30.0)

Burden results for adulterated or substituted test results section 26.183(c)(1) 26.169(c)(4): Record of MRO contact with HHS lab to Duplicative Burden accounted for under discuss whether testing by another HHS lab should be 12.0 2.0 24.0 (24.0)

Burden section 26.185(f)(1) conducted on a specimen with an invalid result Duplicative Burden accounted for under 2.0 1.0 2.0 (2.0)

Burden section 26.183(c)(1) 26.169(f): Records of HHS lab transmittals of CCF copies for Updated 12.0 109.5 1,314.0 26.0 47.1 1,223.6 (90.4) negative results to the MRO Page 10 of 24

Final Supporting Statement, 10 CFR Part 26 Approved Clearance Values Extension Table 2: Annual Recordkeeping (approved 11/30/14 - ICR 201407-3150- (2017-2020)

Index Key:

Burden

- New Total Burden Total Number of Burden Number of Estimate

- Updated Annual Hours per Annual Section Record- Hours per Record- Change

- Moved Burden Record- Burden keepers Recordkeeper keepers

- Duplicative Hours keeper Hours

- Removed 26.169(g): HHS lab copy of the original CCF for each Duplicative Burden accounted for under positive, adulterated, substituted, dilute, and invalid test 12.0 44.7 536.4 (536.4)

Burden section 26.169(c)(1) results to the MRO 26.169(h): Record of HHS lab statistical summary report of Updated 12.0 40.0 480.0 26.0 2.0 52.0 (428.0) urinalysis testing results (for the calendar year)

Updated 26.183(a): Documentation of MRO qualifications 28.0 3.5 98.0 26.0 4.0 104.0 6.0 26.183(c)(1): MRO review of HHS lab test result record for Updated positive, adulterated, substituted, invalid, or at the licensee's 28.0 19.1 534.8 26.0 2.0 51.8 (483.1) or other entity's discretion, dilute specimen 26.183(d)(1)(ii)(D): Record of MRO report of confirmed drug Updated positive, adulterated, substituted, or refusal to test result to 28.0 19.1 534.8 26.0 2.0 51.8 (483.1) the licensees designated reviewing official 26.183(d)(2)(i): Record of MRO staff review and reporting of Updated 28.0 292.2 8,181.6 26.0 282.4 7,341.5 (840.1) negative test results to FFD management 26.183(d)(2)(ii): Record of MRO staff review of CCFs for Updated positive, adulterated, substituted and invalid results and 28.0 1.9 53.2 26.0 2.4 62.1 8.9 forwards changes to MRO for review 26.185(a) Record of MRO review of a drug positive, Burden accounted for under Updated 28.0 26.0 728.0 (728.0) adulterated, substituted, dilute, or invalid HHS lab test result section 26.183(c)(1) 26.185(c): Record of MRO discussion of positive, Updated adulterated, substituted, dilute, or invalid test result with 28.0 26.0 728.0 26.0 11.9 310.5 (417.5) donor Duplicative 26.185(d)(1): Documentation that donor declined to discuss Burden accounted for under section 28.0 2.0 56.0 (56.0)

Burden test results with MRO 26.185(c) 26.185(e): Documentation reviewed by the MRO on a donors Updated inability to discuss test results and a request to reopen 28.0 0.3 8.4 26.0 0.5 13.0 4.6 proceeding 26.185(f)(1): Record of MRO consultation with HHS lab to Updated determine whether additional testing needed for an invalid 28.0 0.5 14.0 26.0 0.5 13.0 (1.0) specimen Duplicative 26.185(f)(2): Record of MRO contact with donor about an Burden accounted for under 28.0 0.5 14.0 (14.0)

Burden invalid test result, and medical information received section 26.185(c)

Duplicative 26.185(h)(1): Record of MRO contact with donor about a Burden accounted for under 28.0 2.0 56.0 (56.0)

Burden substituted test result, and medical information received section 26.185(c)

Duplicative 26.185(h)(2): Record of MRO confirmation of a substituted Burden accounted for under 28.0 2.0 56.0 (56.0)

Burden test result (no legitimate medical explanation) section 26.183(d)(1)(ii)(D)

Duplicative 26.185(h)(3): MRO record of determination of a legitimate Burden accounted for under 28.0 1.0 28.0 (28.0)

Burden medical explanation for a substituted test result section 26.183(d)(2)(i)

Duplicative 26.185(i)(1): Record of MRO contact with donor about an Burden accounted for under 28.0 2.0 56.0 (56.0)

Burden adulterated test result, and medical information received section 26.185(c)

Duplicative 26.185(i)(2): Record of MRO confirmation of an adulterated Burden accounted for under 28.0 2.0 56.0 (56.0)

Burden test result (no legitimate medical explanation) section 26.183(d)(1)(ii)(D)

Duplicative 26.185(i)(3): MRO record of determination of a legitimate Burden accounted for under 28.0 1.0 28.0 (28.0)

Burden medical explanation for an adulterated test result section 26.183(d)(2)(i) 26.185(j): Prescription medication drug positives (applies to amphetamine, morphine, and codeine results) - records of Updated 28.0 1.5 42.0 26.0 2.3 60.0 18.0 MRO review of HHS lab result, discussion of positive result with donor, and review medication information from the donor 26.185(k): Record of MRO report to licensee that no FFD policy violation has occurred (i.e., legitimate prescription medication used in a manner and at the dosage prescribed). Burden accounted for under Duplicative If the individual poses a potential risk to public health and 28.0 1.0 28.0 sections 26.183(d)(2)(i) and 26.185(c) (28.0)

Burden safety because of impairment while on duty - the MRO will ensure that a determination of fitness is performed) 26.185(m): Record of MRO review of inspection and audit reports, QC data, multiple specimens, and other data to determine if positive, adulterated, substituted, or invalid result 28.0 1.0 28.0 26.0 1.0 26.0 (2.0) is scientifically insufficient for determination of FFD policy violation 26.185(n): Record of MRO review of a positive, adulterated or substituted test result from a second HHS lab (results of Updated retesting a single specimen or testing of a Bottle B split 28.0 2.0 56.0 26.0 0.60 15.5 (40.5) specimen), and MRO communication of the test result to the donor, and report results to FFD management 26.185(o): Record of MRO request and HHS lab report of quantitation test results for testing performed on a specimen Updated 28.0 1.5 42.0 26.0 0.50 13.0 (29.0) from a donor applying for reauthorization following a 1st positive drug test result Duplicative 26.185(p): MRO written notice to licensee or other entity of a Burden accounted for under 28.0 8.0 224.0 (224.0)

Burden positive, adulterated, substituted, or invalid test result section 26.185(c)

Page 11 of 24

Final Supporting Statement, 10 CFR Part 26 Approved Clearance Values Extension Table 2: Annual Recordkeeping (approved 11/30/14 - ICR 201407-3150- (2017-2020)

Index Key:

Burden

- New Total Burden Total Number of Burden Number of Estimate

- Updated Annual Hours per Annual Section Record- Hours per Record- Change

- Moved Burden Record- Burden keepers Recordkeeper keepers

- Duplicative Hours keeper Hours

- Removed 26.713(a)(2): Records pertaining to the determination of a Burden accounted for under Consolidated 28.0 80.0 2,240.0 (2,240.0) violation of FFD policy and related management actions section 26.39(b) 26.713(a)(3): Documentation of the granting and termination Updated 28.0 80.0 2,240.0 26.0 80.0 2,080.0 (160.0) of authorization 26.713(a)(4): Records of determinations of fitness Updated performed under section 26.189 (including recommendations 28.0 80.0 2,240.0 26.0 80.0 2,080.0 (160.0) for treatment and followup testing plans)

Duplicative 26.713(b)(1): Records of FFD training and examinations Burden accounted for under 28.0 160.0 4,480.0 (4,480.0)

Burden conducted under section 26.29 sections 26.29(a) and (b)

Duplicative 26.713(b)(2): Records of audits, audit findings, and corrective Burden accounted for under 28.0 80.0 2,240.0 (2,240.0)

Burden actions taken under section 26.41 sections 26.41(a)-(d), (f) and (g) 26.713(c): Records on 5-year and permanent denials of Burden accounted for under Consolidated 28.0 40.0 1,120.0 (1,120.0) authorization section 26.39(b) 26.713(d): Records of superseded versions of FFD policies Updated 28.0 80.0 2,240.0 26.0 8.0 208.0 (2,032.0) and procedures 26.713(e): Records of written agreements for services under Updated 28.0 16.0 448.0 26.0 16.0 416.0 (32.0)

Part 26 26.713(f): Records of background investigations, credit and Duplicative criminal history checks, and psychological assessments of Burden accounted for under 28.0 80.0 2,240.0 (2,240.0)

Burden FFD program personnel conducted under section section 26.31(b)(1)(i) 26.31(b)(1)(i) 26.713(g): Documentation on testing for additional drugs as Moved permitted under section 26.31(d)(1), use of more stringent 28.0 40.0 1,120.0 Moved to Table 1 (1,120.0)

(to Table 1) testing cutoff levels as permitted under section 26.31(d)(3),

or both 26.715(a): Documentation of all aspect of testing process at Updated collection sites and LTFs (not otherwise specified in section 28.0 40.0 1,120.0 26.0 40.0 1,040.0 (80.0) 26.715(b))

26.715(b)(1): Retain personnel files on staff at collection sites Updated 28.0 20.0 560.0 26.0 20.0 520.0 (40.0) and LTFs 26.715(b)(2): Retain collection site and LTF chain-of-custody Updated 28.0 240.0 6,720.0 26.0 240.0 6,240.0 (480.0) documents Updated 26.715(b)(3): Retain LTF QA/QA records 28.0 120.0 3,360.0 6.0 120.0 720.0 (2,640.0) 26.715(b)(4): Retain superseded procedures (LTFs and Updated 28.0 40.0 1,120.0 26.0 40.0 1,040.0 (80.0) collection sites) 26.715(b)(5): Retain all test data from LTF (including Updated calibration curves and any calculations used in determining 28.0 240.0 6,720.0 6.0 240.0 1,440.0 (5,280.0) test results Updated 26.715(b)(6): LTF test reports 28.0 240.0 6,720.0 6.0 240.0 1,440.0 (5,280.0)

Updated 26.715(b)(7): LTF performance testing records 28.0 80.0 2,240.0 6.0 80.0 480.0 (1,760.0) 26.715(b)(8): Records from LTF and HHS lab on the Updated investigation of testing errors or unsatisfactory performance, 28.0 40.0 1,120.0 8.0 40.0 320.0 (800.0) and any corrective actions taken Moved 26.715(b)(9): Performance records on HHS lab certification 28.0 40.0 1,120.0 Moved to Table 4 (1,120.0)

(to Table 4) inspections 26.715(b)(10): Records of preventative maintenance on LTF Updated 28.0 40.0 1,120.0 6.0 40.0 240.0 (880.0) instruments 26.715(b)(11): Retain records that summarize any test Updated results the MRO determined to be scientifically insufficient for 28.0 20.0 560.0 1.0 3.0 3.0 (557.0) further action Updated 26.715(b)(12): LTF retains computer-generated data 28.0 120.0 3,360.0 6.0 120.0 720.0 (2,640.0) 26.715(b)(13): Retain records (e.g., an access log) of Duplicative Burden accounted for under section authorized visitors, maintenance personnel and service 28.0 20.0 560.0 (560.0)

Burden 26.129(a) personnel who accessed LTF secure areas 26.715(b)(14): Retain records of the inspection, maintenance Updated 28.0 20.0 560.0 26.0 20.0 520.0 (40.0) and calibration of EBTs (collection sites) 26.717(a) and (b): Collect FFD performance data for D&A 28.0 100.0 2,800.0 26.0 100.0 2,600.0 (200.0) testing programs 26.717(a) and (b): Collect FFD performance data for fatigue 23.0 100.0 2,300.0 21.0 100.0 2,100.0 (200.0) management program 26.717(c): Analyze D&A testing program FFD data annually 28.0 40.0 1,120.0 26.0 40.0 1,040.0 (80.0) 26.717(c): Analyze fatigue management program data 23.0 40.0 920.0 21.0 40.0 840.0 (80.0) annually 26.717(d): D&A test results leading to termination 1.0 1.0 1.0 1.0 1.0 1.0 -

Duplicative 26.717(g): Collect and report D&A testing program data to Burden accounted for under 1.0 120.0 120.0 (120.0)

Burden the NRC (for C/V with a testing program) section 26.717(a) and (b) 26.719(b): Prepare information to make a 24-hour event Updated 1.2 1.0 1.2 37.0 1.0 37.0 35.8 report to the NRC Updated 26.719 (c): Prepare 30-day event report documentation. 0.2 40.0 8.0 8.0 40.0 320.0 312.0 26.719(d): Document non-reportable indicators of FFD 30.0 20.0 600.0 28.0 20.0 560.0 (40.0) program weaknesses Page 13 of 24

Final Supporting Statement, 10 CFR Part 26 Approved Clearance Values Extension Table 2: Annual Recordkeeping (approved 11/30/14 - ICR 201407-3150- (2017-2020)

Index Key:

Burden

- New Total Burden Total Number of Burden Number of Estimate

- Updated Annual Hours per Annual Section Record- Hours per Record- Change

- Moved Burden Record- Burden keepers Recordkeeper keepers

- Duplicative Hours keeper Hours

- Removed 26.187(d): SAE training requirements 28.0 20.0 560.0 26.0 20.0 520.0 (40.0) 26.187(f): Documentation of SAE credentials and training 28.0 1.0 28.0 26.0 1.0 26.0 (2.0)

Updated 26.189(b): Determination of fitness record 28.0 80.2 2,245.6 26.0 80.0 2,080.0 (165.6)

Updated 26.189(c): Record of for cause determination of fitness 28.0 16.3 456.4 26.0 15.6 405.3 (51.1) 26.189(d): Record of modification of an initial determination Updated 28.0 1.0 28.0 1.0 1.0 1.0 (27.0) of fitness 26.203(a): Prepare fatigue management policy (In addition to 2.0 7.3 14.6 0 7.3 - (14.6) 26.27 burden) 26.203(b): Prepare fatigue management procedures (in 2.0 1.7 3.4 0 1.7 - (3.4) addition to 26.27 burden) 26.203(c): Prepare training on fatigue management. 2.0 2.0 4.0 0 2.0 - (4.0) 26.203(d)(1) and (d)(2): Records of work hours, shift Burden accounted for under Burden accounted for under Updated -

schedules, and shift cycles 26.205(c), (d)(1), and (e)(4) 26.205(c), (d)(1), and (e)(4)

Burden accounted for under Burden accounted for under 26.203(d)(3): Documentation of waivers -

section 26.207(a)(4) section 26.207(a)(4)

Burden accounted for under Burden accounted for under 26.203(d)(4): Documentation of work hour reviews -

26.205(d)(2), (e)(3) and (e)(4) 26.205(d)(2), (e)(3) and (e)(4)

Burden accounted for under Burden accounted for under 26.203(d)(5): Documentation of fatigue assessment -

section 26.211(f) section 26.211(f) 26.205(b): Record of calculation of work hours 23.0 160.0 3,680.0 21.0 160.0 3,360.0 (320.0) 26.205(c): Schedule work hours 23.0 2,080.0 47,840.0 21.0 2,080.0 43,680.0 (4,160.0) 26.205(d)(1): Record of implementation of work hour 23.0 50.0 1,150.0 21.0 50.0 1,050.0 (100.0) controls 26.205(d)(2): Record of adequate rest breaks 23.0 50.0 1,150.0 21.0 50.0 1,050.0 (100.0) 26.205(e)(1) and (2): Record of review of control of work 23.0 40.0 920.0 21.0 40.0 840.0 (80.0) hours twice per calendar year 26.205(e)(3): Document methods for reviews 23.0 20.0 460.0 21.0 20.0 420.0 (40.0) 26.205(e)(4): Record and trend problems in regarding work 23.0 20.0 460.0 21.0 20.0 420.0 (40.0) hours Updated 26.207(a)(4): Document basis for waiver 3.0 6.0 18.0 21.0 6.0 126.0 108.0 26.211(f): Document results of fatigue assessments 23.0 50.0 1,150.0 21.0 50.0 1,050.0 (100.0) 26.403(a): Updates to FFD policy and procedures NEW Not included in clearance 2.0 16.0 32.0 32.0 (reactor construction site D&A testing program)

Moved 26.403(a): Provide FFD policy to individuals subject to a Moved from Table 1 2.0 8.0 16.0 16.0 (from Table 1) reactor construction site D&A testing program Updated 26.405(b): Records of random D&A tests 2.0 705.0 1,410.0 2.0 193.9 387.7 (1,022.3)

Updated 26.405(c)(1): Records of pre-assignment D&A test 2.0 2,338.0 4,676.0 2.0 287.4 574.8 (4,101.2) 26.405(c)(2) and (c)(3): Records of for-cause and post Updated 2.0 197.0 394.0 2.0 308.8 617.7 223.7 accident D&A tests Updated 26.405(c)(4): Records of follow-up D&A tests 2.0 34.5 69.0 2.0 21.1 42.1 (26.9)

Moved 26.405(d): Record of testing for specified drugs, adulterants, Burden accounted for under Moved to Table 1 -

(to Table 1) and alcohol, at Part 26 specified cutoff levels section 26.405(a) - (c)(4) 26.405(e): Updates to specimen collection and D&A testing procedures to protect the donor's privacy, integrity of the Updated 2.0 40.0 80.0 2.0 40.0 80.0 -

specimen, and stringent quality controls to ensure accurate test results 26.405(f): Record that testing conducted at an HHS lab 2.0 40.0 80.0 2.0 40.0 80.0 -

26.405(g): Record of MRO review of positive, adulterated, Updated substituted, and invalid drug and validity test results (reactor 2.0 50.0 100.0 2.0 81.3 162.5 62.5 construction site D&A testing program) 26.406(c): Updates to fitness monitoring procedures Updated (programs that do not adopt random testing and behavioral - 80.0 - 0 80.0 - -

observation) 26.411(a): Updates to procedures for maintaining a system Updated of files to protect personal information collected under 2.0 4.0 8.0 2.0 40.0 80.0 72.0 Subpart K of Part 26 26.411(a) and (b): Collection of personal information under Updated Subpart K of Part 26 2.0 2,190.5 4,381.0 2.0 3,817.0 7,634.0 3,253.0 26.413: Document results of review process 2.0 80.0 160.0 2.0 80.0 160.0 -

26.415: Document and report audit results 2.0 40.0 80.0 2.0 40.0 80.0 -

26.417(a): Records pertaining to the administration of a Updated 2.0 20.0 40.0 2.0 20.0 40.0 -

reactor construction site D&A testing program 26.417(b)(1): Report to NRC by telephone within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> Burden accounted for under NEW programmatic failures in a reactor construction site D&A Not included in clearance section 26.719(b) testing program 26.417(b)(2) Collect FFD program performance data for Updated 2.0 100.0 200.0 2.0 100.0 200.0 -

reactor construction site D&A testing program 26.713(a)(1): Records of self-disclosures, employment Duplicative Burden accounted for under section histories, and suitable inquiries (under sections 26.55, 26.57, 28.0 80.0 2,240.0 (2,240.0)

Burden 26.61(a), and 26.63(a), (c), and (e) 26.59, and 26.69) that result in the granting of authorization Page 12 of 24

Final Supporting Statement, 10 CFR Part 26 Approved Clearance Values Extension Table 2: Annual Recordkeeping (approved 11/30/14 - ICR 201407-3150- (2017-2020)

Index Key:

Burden

- New Total Burden Total Number of Burden Number of Estimate

- Updated Annual Hours per Annual Section Record- Hours per Record- Change

- Moved Burden Record- Burden keepers Recordkeeper keepers

- Duplicative Hours keeper Hours

- Removed 26.821(a): Provide NRC with access to records (to inspect, Updated 30.0 4.0 120.0 28.0 4.0 112.0 (8.0) copy, or take away copies of records) 26.821(b): Written agreement between C/Vs and licensees to Updated permit authorized NRC representatives to inspect, copy, or 1.0 4.0 4.0 1.0 4.0 4.0 -

take away copies of C/Vs documents, records, and reports Table 2 Total 314,177.4 220,886.5 (93,290.9)

-29.7%

Page 14 of 24

FINAL Supporting Statement, 10 CFR Part 26 Approved Clearance Values Extension Table 3: Annual Reporting (approved 11/30/14 - ICR 201407-3150-007) (2017-2020) Burden Index Key: Responses Burden per Total Responses Burden per Total Estimate Number Total Number Total

- Updated Section per Response Burden per Response Burden Change of Respondents Responses of Respondents Responses

- Removed Respondent (hours) Hours Respondent (hours) Hours 26.9: Application to NRC for exemption 0 1.0 - - - 0 1.0 - - - -

Updated 26.77(c) Report impaired NRC employee 30.0 - - 1.0 - 0 - - 1.0 - -

26.137(b)(3): Report false negative LTF No LTF conducts validity screening testing Updated Burden accounted for under section 26.719(c)(3) -

validity screening result (if any did, burden would be accounted for under section 26.719(c)(3) 26.139(d): Prepare information from LTF for REMOVED Removed Burden accounted for under section 26.717(e) and (f) -

annual FFD program performance report (Activity covered in Table 2) 26.187(f): Provide SAE qualifications REMOVED Removed 1.0 1.0 1.0 1.0 1.0 (1.0) documentation to NRC upon request (Activity covered in Table 2) 26.203(e)(1): Prepare information on waivers of work hour controls for inclusion Updated 23.0 1.0 23.0 50.0 1,150.0 21.0 1.0 21.0 50.0 1,050.0 (100.0) in FFD program performance report to NRC required by 26.717 26.203(e)(2): Prepare summary of fatigue 6.0 corrective actions for inclusion in FFD Updated 23.0 1.0 23.0 138.0 21.0 1.0 21.0 6.0 126.0 (12.0) program performance report to NRC required by 26.717 26.417(b)(1): Report to NRC by telephone within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of identifying a Updated 2.0 1.0 2.0 4.0 8.0 Burden accounted for under section 26.719(b) (8.0) programmatic failure in a reactor construction site D&A testing program 26.417(b)(2): Prepare annual FFD program Updated performance report for reactor construction 2.0 1.0 2.0 80.0 160.0 2.0 1.0 2.0 80.0 160.0 -

site D&A testing program Burden accounted for under section 26.717(e) and (f). NRC's 2012 FFD program 26.717(d): Report termination drug and Removed Removed alcohol test results in annual program performance indicate 1,089 positive, adulterated, substituted, and refusal to test -

(All burden is captured under a single 26.717 line items for D&A results) performance summary by processing stage results.

26.717: Annual FFD program performance Updated 62.0 1.0 62.0 8.0 496.0 59.0 1.0 59.0 8.0 472.0 (24.0) report for fatigue management programs 26.717: Annual FFD program performance Updated 65.0 1.0 65.0 60.0 3,900.0 67.0 1.0 67.0 60.0 4,020.0 120.0 for D&A testing programs 26.719(a): Report a significant FFD Updated program violation, programmatic failure, or Burden accounted for under section 26.719(b) and (c) Burden reported under sections 26.719(b), and (c)(1) - (c)(3) -

D&A testing error 26.719(b): Report to the NRC by telephone Updated within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of identifying a significant 15.0 2.5 37.1 4.0 148.2 37.0 1.0 37.0 4.0 148.0 (0.2)

D&A testing violation 26.719(c)(1): Submit a report to the NRC within 30 days of completing an Updated 6.0 1.0 6.0 24.0 144.0 8.0 1.0 8.0 24.0 192.0 48.0 investigation into an LTF or HHS lab testing error 26.719(c)(2): Notify the NRC by telephone Updated within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of receiving notice of a false 1.0 1.0 1.0 4.0 4.0 0 1.0 - 4.0 - (4.0) positive on a BPTS test result 26.719(c)(3): Notify the NRC by telephone within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of receiving a false negative Updated 4.0 1.0 4.0 4.0 16.0 0 1.0 - 4.0 - (16.0) test result on a QA check of a validity screening test from an LTF Table 3 Total 226.1 6,165.2 215.0 6,168.0 2.8 Page 15 of 24

FINAL Supporting Statement, 10 CFR Part 26 Table 4: Annual Third-Party Disclosure Approved Clearance Values Extension (approved 11/30/14 - ICR 201407-3150-007) (2017-2020)

Index Key:

- Consolidated Burden

- Duplicative Total Total Estimate Number Burden Burden

- Moved Section Annual Number Annual Change of Hours per Hours per

- New Burden of Responses Burden Responses Response Response

- Removed Hours Hours

- Updated 26.4(j): For personnel granted authorization by a licensee, who are covered by a D&A testing program regulated by a State or Federal agency - (1) provision of training record to the licensee to demonstrate section 26.29(a) training Updated requirements met (if not already covered in the existing 14.0 2.0 28.0 33.5 2.0 67.0 39.0 program); (2) notification of any FFD policy violations by those granted authorization by the licensee or other entity Moved 26.29(b): Complete initial training on FFD policy and take Not included in clearance 81,219.3 2.0 162,438.6 162,438.6 (from Table 1) comprehensive examination (was in Table 1 but zero programs)

Moved 26.29(c)(2): Complete annual refresher training on FFD Not included in clearance 103,932.7 1.5 155,899.0 155,899.0 (from Table 1) policy (was in Table 1 but zero programs) 26.31(b)(1)(i): Individual applying for access to serve as FFD program personnel provides background check Updated information for the background investigation, credit and 93,890.0 1.0 93,890.0 335.0 1.0 335.0 (93,555.0) criminal history checks, and psychological assessment 26.31(d)(6): Donor provides written permission to conduct Removed Removed 8.0 1.0 8.0 (8.0) another analysis or test with specimen (not an information collection)

Updated 26.35(a): Employee assistance program (EAP) records 14.0 32.0 448.0 26.0 32.0 832.0 384.0 26.35(c): Individual completes and provides the EAP with a Updated written waiver of right to privacy to share information with 5,636.0 0.3 1,690.8 1,039.3 0.25 259.8 (1,431.0)

FFD management 26.35(c): Record of EAP disclosure to FFD management Updated 15.0 1.0 15.0 13.0 1.0 13.0 (2.0) about an individual that poses an immediate hazard 26.37(b): Individuals provide signed consent for release of Updated 1,127.0 0.3 338.1 258.0 0.25 64.5 (273.6) information 26.37(b)(1): Individual provides signed designation of Updated 961.0 1.0 961.0 258.0 0.25 64.5 (896.5) personal representative for an FFD matter 26.37(d): Request by donor or donors presentative to the Updated licensee or other entity to provide personal records collected 961.0 1.0 961.0 26.0 0.25 6.5 (954.5) under Part 26 26.53(h): Applicant provides written consent before any Updated 93,890.0 0.3 28,167.0 81,219.3 0.25 20,304.8 (7,862.2) actions are initiated under Subpart C of Part 26 26.55(a)(1) - (a)(2): Initial authorization 26.57(a)(1) - (a)(2): Authorization update 26.59(a)(1) - (a)(2): Authorization reinstatement Burden accounted for under Burden accounted for under Updated Each individual applying for authorization must complete a -

sections 26.61 and 26.63 sections 26.61(a) and 26.63(a),(c) and (e) self-disclosure, employment history, and suitable inquiry 26.59(c)(1): Applicant prepares self-disclosure (for Burden accounted for under Burden accounted for under Updated authorization reinstatement period of interruption of no more -

section 26.61 sections 26.61(a) than 30 days) 26.61(a): Applicant prepares self-disclosure and Updated 93,890.0 1.0 93,890.0 81,219.3 1.0 81,219.3 (12,670.7) employment history 26.63(a), (c), and (e): Former employer(s) provide information to the licensee or other entity to verify an Updated applicants suitable inquiry information on previous 93,890.0 0.80 75,112.0 81,219.3 0.75 60,914.5 (14,197.5) authorization(s) 26.63(c)(2): U.S. Department of Defense (DOD) provides Burden of supplying DD 214 affects DOD, or Updated licensee or other entity with form DD 214 which details an Burden of supplying DD 214 affects DOD is accounted for under section 26.61(a) (if -

applicants military service record supplied by the applicant) 26.63(c)(3): Former employer refuses to provide information Updated to the licensee or other entity about an applicants prior 180.0 0.5 90.0 180.0 0.1 15.0 (75.0) employment history 26.67: Records of random D&A testing of persons who have Updated applied for authorization, but who have not been granted 335.0 0.5 167.5 406.1 0.5 203.0 35.55 unescorted access authorization 26.69(b) and (c)(1): Applicant provides written self-disclosure and employment history to the licensee or other entity (for authorization following a 1st or 2nd positive drug Burden accounted for under Burden accounted for under Updated -

or alcohol test result, or if other PDI is identified) section 26.63 section 26.61(a) 26.69(c)(2): Former employer(s) of an applicant provide Updated response to licensee or other entity request to confirm 939.0 2.0 1,878.0 812.2 2.0 1,624.4 (253.6) suitable inquiry information for an applicant with PDI 26.85(c): Alternative collectors not employed by licensee Updated 22.0 1.0 22.0 26.0 1.0 26.0 4.0 provide proof of qualification 26.85(e): Maintain personnel files for alternative collectors Updated 22.0 4.0 88.0 26.0 4.0 104.0 16.0 Page 16 of 24

FINAL Supporting Statement, 10 CFR Part 26 Table 4: Annual Third-Party Disclosure Approved Clearance Values Extension (approved 11/30/14 - ICR 201407-3150-007) (2017-2020)

Index Key:

- Consolidated Burden

- Duplicative Total Total Estimate Number Burden Burden

- Moved Section Annual Number Annual Change of Hours per Hours per

- New Burden of Responses Burden Responses Response Response

- Removed Hours Hours

- Updated 26.87(f)(1), and (f)(3) - (f)(5): Post a sign outside the collection area (if a public restroom) and document on the custody-and-control form (CCF) the name of a same gender Consolidated observer (in the exceptional event that a designated 2.0 1.0 2.0 Consolidated in Table 2 (2.0)

(in Table 2) collection site is inaccessible, the collector is not the same gender as the donor and a urine specimen must be immediately collected) 26.89(a): Record that a donor did not appear for testing (non Updated 2.0 1.0 2.0 2.0 1.0 2.0 -

licensee collection site) 26.89(b)(3): Record FFD management informed that an Updated individual did not present identification (non-licensee 2.0 1.0 2.0 2.0 1.0 2.0 -

collection site) 26.89(c): Record that FFD management informed that a Updated donor refused to cooperate with the collection procedures 2.0 1.0 2.0 - 0.25 - (2.0)

(non-licensee collection site) 26.91(e)(4): Record that results cancelled after EBT Updated 1.0 1.0 1.0 - 1.0 - (1.0) calibration check failure (non-licensee collection site) 26.91(e)(5): Prepare record of EBT maintenance (non-Updated 22.0 4.0 88.0 26.0 4.0 104.0 16.0 licensee collection site) 26.93(a)(6): Document alcohol pre-test questions asked and Updated 280.0 0.3 84.0 260.0 0.25 65.0 (19.0) answered (non-licensee collection site) 26.95(b)(5): Record donor identity for initial alcohol breath Updated 280.0 0.3 84.0 260.0 0.25 65.0 (19.0) test (non-licensee collection site) 26.97(b)(2): Record reason for new oral fluid alcohol test Updated 8.0 0.5 4.0 - 0.5 - (4.0)

(non-licensee collection site) 26.97(c)(1): Document reason for failure of second Updated 1.0 1.0 1.0 - 1.0 - (1.0) collection attempt (non-licensee collection site) 26.97(d): Record results and alcohol screening device used Updated 8.0 0.3 2.4 - 0.25 - (2.40)

(non-licensee collection site)

Duplicative 26.99(b): Record test time of initial test with 0.02 percent Burden accounted for under 1.0 0.3 0.3 (0.30)

Burden BAC or higher (non-licensee collection site) section 26.715(b)(2)

Duplicative 26.101(b)(7): EBT printout of confirmatory alcohol test result Burden accounted for under 1.0 0.3 0.3 (0.30)

Burden includes time of test (non-licensee collection site) section 26.715(b)(2) 26.103(b): Collector informs FFD management of result Updated between 0.01 and 0.02 percent BAC when donor in work - 0.5 - - 0.25 - -

status 3 or more hours (non-licensee collection site)

Duplicative 26.107(b): Collector documents tampering attempt on CCF Burden accounted for under

- 1.0 - -

Burden form (non-licensee collection site) section 26.111(b) 26.109(b)(3): Collector documents on CCF sh- bladder Updated situation and notifies FFD management (non-licensee - 0.5 - - 0.25 - -

collection site) 26.109(b)(4): Collector documents on CCF confirmation Updated from FFD management to conduct a an observed collection - 0.3 - - 0.25 - -

(non-licensee collection site) 26.111(b): Collector documents on CCF if specimen Updated characteristics (color, clarity) indicate possible tampering by 2.0 0.5 1.0 - 0.25 - (1.0) the donor (non-licensee collection site) 26.111(c): Collector documents on CCF unusual specimen temperature and/or other observations made during the Updated collection of possible tampering attempt and notifies FFD - 0.4 - 0.25 - -

management (non-licensee collection site)

Duplicative 26.113(b)(3): Collector completes CCF for split-specimen Burden accounted for under

- 0.3 - -

Burden collection (non-licensee collection site) section 26.117(c) - (e) 26.115(b): Collector documents on CCF approval from FFD Updated manager or MRO to collect a specimen under direct - 0.3 - - 0.25 - -

observation (non-licensee collection site) 26.115(d): Collector documents on CCF directly observed Burden accounted for under Updated collection performed and the reason for the observed - 0.3 - -

section 26.115(b) collection (non-licensee collection site) 26.115(f)(3): Record of name of observer (non-licensee

- 0.3 - - 0.25 - -

collection site) 26.117(c) - (e): Collector prepares ID labels and CCF forms Updated for specimen shipment (non-licensee collection site) 280.0 0.3 84.0 260.0 0.25 65.0 (19.0) 26.119(a), (e), and (f): Physician evaluating shy-bladder Updated claim prepares report of medical examination of donor and - 6.0 - 13.0 2.0 26.0 26.0 provides this information to the MRO Consolidated 26.119(b): MRO provides information to physician as

- 2.0 - Consolidated in Table 2 -

(in Table 2) background for evaluation of a shy bladder claim 26.129(b): Collector prepares memorandum to and sends to Updated LTF documenting investigation of discrepancies between - 1.0 - 1.0 - -

bottles and CCF (non-licensee collection site)

Page 17 of 24

FINAL Supporting Statement, 10 CFR Part 26 Table 4: Annual Third-Party Disclosure Approved Clearance Values Extension (approved 11/30/14 - ICR 201407-3150-007) (2017-2020)

Index Key:

- Consolidated Burden

- Duplicative Total Total Estimate Number Burden Burden

- Moved Section Annual Number Annual Change of Hours per Hours per

- New Burden of Responses Burden Responses Response Response

- Removed Hours Hours

- Updated 26.135(b): Donor request to MRO for the retesting of an aliquot of a single specimen or the testing of the Bottle B Burden accounted for under Updated split specimen at a second HHS lab (initial specimen testing 1.0 0.5 0.5 (0.50) section 26.165(b)(1) performed at an LTF) 26.137(b)(3): LTF records submitting 1 in 10 negative Not Third Party Burden Removed specimens for validity screening to HHS lab - 40.0 - -

(accounted for in Table 2) 26.153(g): Supply memorandum to HHS lab explaining use Updated of non-federal CCF form (non-licensee collection site) 2.0 0.5 1.0 2.0 0.5 1.0 -

26.155(a)(1): Document of HHS lab manager qualifications Burden covered by HHS lab certification Burden covered by HHS lab certification Updated -

requirements OMB Clearance # 0930-0158 requirements OMB Clearance No. 0930-0158 26.155(a)(3): HHS lab personnel training documentation Burden covered by HHS lab certification Burden covered by HHS lab certification Updated -

requirements OMB Clearance # 0930-0158 requirements OMB Clearance No. 0930-0158 26.155(a)(4): HHS lab manager reviews and approved lab Burden covered by HHS lab certification Burden covered by HHS lab certification Updated procedures -

requirements OMB Clearance # 0930-0158 requirements OMB Clearance No. 0930-0158 26.155(a)(5): HHS lab manager maintains QA program Burden covered by HHS lab certification Burden covered by HHS lab certification Updated -

requirements OMB Clearance # 0930-0158 requirements OMB Clearance No. 0930-0158 26.155(b): Certifying scientist at HHS lab certifies test Burden covered by HHS lab certification Burden covered by HHS lab certification Updated results -

requirements OMB Clearance # 0930-0158 requirements OMB Clearance No. 0930-0158 26.155(c): Supervise technical analysts at HHS lab Burden covered by HHS lab certification Burden covered by HHS lab certification

-

requirements OMB Clearance # 0930-0158 requirements OMB Clearance No. 0930-0158 26.155(e): Continuing education of HHS lab staff Burden covered by HHS lab certification Burden covered by HHS lab certification Updated -

requirements OMB Clearance # 0930-0158 requirements OMB Clearance No. 0930-0158 26.155(f): HHS lab personnel records Burden covered by HHS lab certification Burden covered by HHS lab certification Updated -

requirements OMB Clearance # 0930-0158 requirements OMB Clearance No. 0930-0158 26.157(a): Written HHS lab procedures for accession, Burden covered by HHS lab certification Burden covered by HHS lab certification Updated receipt, shipment, and testing of urine specimens -

requirements OMB Clearance # 0930-0158 requirements OMB Clearance No. 0930-0158 26.157(b): Written HHS lab chain-of-custody procedures for Burden covered by HHS lab certification Burden covered by HHS lab certification HHS lab -

requirements OMB Clearance # 0930-0158 requirements OMB Clearance No. 0930-0158 26.157(c): Written HHS lab procedures for each testing Burden covered by HHS lab certification Burden covered by HHS lab certification Updated assay performed -

requirements OMB Clearance # 0930-0158 requirements OMB Clearance No. 0930-0158 26.157(d): Written HHS lab procedures for device set-up Burden covered by HHS lab certification Burden covered by HHS lab certification Updated and operation -

requirements OMB Clearance # 0930-0158 requirements OMB Clearance No. 0930-0158 26.157(e): Written HHS lab procedures for remedial actions Burden covered by HHS lab certification Burden covered by HHS lab certification Updated to address system and instrument errors -

requirements OMB Clearance # 0930-0158 requirements OMB Clearance No. 0930-0158 26.159(a): Retain records (e.g., an access log) of authorized Burden covered by HHS lab certification Burden covered by HHS lab certification Updated visitors, maintenance personnel, and service personnel who -

requirements OMB Clearance # 0930-0158 requirements OMB Clearance No. 0930-0158 accessed secure areas of HHS lab 26.159(b)(1): Record that the HHS lab notified the licensee NEW or other entity within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of identifying evidence of Not included in previous clearance 0 1.0 -

specimen tampering 26.159(c) - (e): Use and storage of CCF forms at HHS lab Burden covered by HHS lab certification Burden accounted for under Updated -

requirements OMB Clearance # 0930-0158 section 26.715(b)(2) 26.159(f): Use of CCF by HHS lab when shipping a Burden covered by HHS lab certification Burden accounted for under Updated -

specimen to another HHS lab requirements OMB Clearance # 0930-0158 section 26.165(b)(1) 26.165(b)(1): At the direction of the MRO, the initial HHS lab that conducted testing send a donors specimen (i.e., an Updated aliquot of a single specimen or Bottle B of the split 1.0 1.0 1.0 31.1 1.0 31.1 30.1 specimen) to a second HHS lab for further testing 26.165(b)(2): Record that MRO informed the donor of the Consolidated opportunity to request the retesting of an aliquot of a single 1.0 0.3 0.3 Consolidated in Table 2 (0.30)

(in Table 2) specimen or the testing of the Bottle B split specimen at a second HHS lab 26.165(b)(3): Donor provides written request to the MRO for Updated the retesting of an aliquot of a single specimen or the testing 1.0 1.0 1.0 31.1 1.0 31.1 30.1 of the Bottle B split specimen 26.165(b)(4): Donor presents documentation to the MRO on Duplicative Burden accounted for under the reason for not being able to make a timely retest request - 1.0 - -

Burden section 26.185(e)

Page 18 of 24

FINAL Supporting Statement, 10 CFR Part 26 Table 4: Annual Third-Party Disclosure Approved Clearance Values Extension (approved 11/30/14 - ICR 201407-3150-007) (2017-2020)

Index Key:

- Consolidated Burden

- Duplicative Total Total Estimate Number Burden Burden

- Moved Section Annual Number Annual Change of Hours per Hours per

- New Burden of Responses Burden Responses Response Response

- Removed Hours Hours

- Updated 26.165(b)(6) HHS lab provides report to the MRO of the Duplicative quantitative test results of the retesting of aliquot of a single Burden accounted for under specimen or the testing of the Bottle B split specimen 1.0 0.5 0.5 (0.50)

Burden section 26.185(n) 26.167(a): HHS lab documents QA program (encompasses Burden covered by HHS lab certification Burden covered by HHS lab certification Updated all aspects of the testing process) -

requirements OMB Clearance # 0930-0158 requirements OMB Clearance No. 0930-0158 26.167(c)(2)(i): Refractometer at the HHS lab must display specific gravity to 4 decimals and be interfaced with laboratory information management system or computer Burden covered by HHS lab certification Burden covered by HHS lab certification

-

and/or document result by hard copy or electronic display requirements OMB Clearance # 0930-0158 requirements OMB Clearance No. 0930-0158 26.167(f)(3): False positive error on BPTS test and the error is technical or methodological, the HHS lab Responsible Person must document that retesting of all positive, adulterated, substituted, and invalid specimens from the Burden covered by HHS lab certification Updated time of final resolution of the error back to the time of the - 8.0 - -

requirements OMB Clearance # 0930-0158 last satisfactory performance test cycle has been completed, as requested by the licensee or other entity 26.167(h): HHS lab labels standards and controls Burden covered by HHS lab certification Burden covered by HHS lab certification Updated -

requirements OMB Clearance # 0930-0158 requirements OMB Clearance No. 0930-0158 26.168(a): Blind performance test sample (BPTS) supplier provides HHS lab certification letter of BPTS formulation to Burden covered by HHS lab certification Updated 2.0 8.0 16.0 16.0 licensee or other entity requirements OMB Clearance # 0930-0158 26.168(h)(2): BPTS sample supplier provides expiration Burden covered by HHS lab certification Updated date on each BPTS 2.0 8.0 16.0 16.0 requirements OMB Clearance # 0930-0158 26.168(i)(2): Licensee or other entity completes CCF for a Moved BPTS, places fictional initials on specimen labels, and Burden covered by HHS lab certification indicates on the MRO copy of the CCF that the specimen is Moved to Table 2 -

(to Table 2) requirements OMB Clearance # 0930-0158 a BPTS 26.169(a): HHS lab reports test results to the MRO of the Burden covered by HHS lab certification Burden accounted for under Updated licensee or other entity -

requirements OMB Clearance # 0930-0158 section 26.169(c)(1) 26.169(c)(1): HHS lab provides record to the MRO for each Updated positive, adulterated, substituted, dilute, and invalid test 686.0 0.25 171.5 621.0 0.25 155.3 (16.3) result Duplicative 26.169(c)(2): HHS lab provides quantitative test result Burden accounted for under 5.0 1.0 5.0 (5.0)

Burden record for positive drug test (at the request of the MRO) section 26.169(c)(1)

Duplicative 26.169(c)(2): HHS lab record of quantitative test results for Burden accounted for under 16.0 1.0 16.0 (16.0)

Burden opiates to the MRO (at the request of the MRO) section 26.169(c)(1) 26.169(c)(3): HHS lab provides quantitative test result Duplicative Burden accounted for under record for adulterated or substituted test results (at the 5.0 1.0 5.0 (5.0)

Burden section 26.169(c)(1) request of the MRO) 26.169(c)(4): HHS lab record of contact with MRO to Updated discuss if additional testing by another HHS lab should be 10.0 0.5 5.0 10.0 0.5 5.0 -

conducted on a specimen with an invalid test result 26.169(f): HHS lab transmits to the MRO a copy of CCF for Burden accounted for under Updated Electronic transmission -

specimens with negative test results section 26.715(b)(2) 26.169(g): HHS lab transmits to the MRO a copy of the Duplicative original CCF signed by the certifying scientist (for positive, Burden accounted for under adulterated, substituted, dilute and invalid test result) 686.0 0.5 343.0 (343.0)

Burden section 26.169(c)(1) 26.169(h): HHS lab prepares and submits annual statistical Updated summary report of urinalysis testing results 10.0 40.0 400.0 67.0 2.0 134.0 (266.0)

Consolidated 26.183(a): Documentation of MRO qualifications 28.0 1.0 28.0 Consolidated in Table 2 (28.0)

(in Table 2) 26.183(c)(1): MRO review of records for positive, Consolidated adulterated, substituted, invalid, or, at the licensees or other Burden accounted for under section 26.185(a) Consolidated in Table 2 -

(in Table 2) entity's discretion, dilute test results that confirm as an FFD violation Consolidated 26.183(d)(2)(i): Record of MRO staff review and reporting of 16,383.0 0.1 819.2 Consolidated in Table 2 (819.15)

(in Table 2) negative test results Consolidated 26.183(d)(2)(ii): Record of MRO staff review of CCF forms 54.0 0.1 5.4 Consolidated in Table 2 (5.40)

(in Table 2) and forward changes to MRO 26.185(a) Record of MRO review of all positive, adulterated, Consolidated substituted, or invalid test results and report to licensee or 635.0 1.0 635.0 Consolidated in Table 2 (635.0)

(in Table 2) other entity 26.185(c): Donor discussion with MRO of positive, Updated 635.0 1.0 635.0 621.0 0.5 310.5 (324.5) adulterated, substituted, dilute, or invalid test result Page 19 of 24

FINAL Supporting Statement, 10 CFR Part 26 Table 4: Annual Third-Party Disclosure Approved Clearance Values Extension (approved 11/30/14 - ICR 201407-3150-007) (2017-2020)

Index Key:

- Consolidated Burden

- Duplicative Total Total Estimate Number Burden Burden

- Moved Section Annual Number Annual Change of Hours per Hours per

- New Burden of Responses Burden Responses Response Response

- Removed Hours Hours

- Updated Consolidated 26.185(d)(1): Documentation that donor declined to discuss 81.0 1.0 81.0 Consolidated in Table 2 (81.0)

(in Table 2) test results 26.185(e): Donor provides documentation to the MRO Updated demonstrating an inability to discuss test results and 8.0 1.0 8.0 8.0 1.0 8.0 -

requesting the test result determination be reopened 26.185(f)(1): HHS lab consultation with MRO on whether Burden accounted for under Updated additional testing of a specimen with an invalid test result 26.0 0.50 13.0 13.0 section 26.185(c) should be performed at a second HHS lab 26.185(f)(2): Donor discussion with MRO regarding an Burden accounted for under Burden accounted for under Updated -

invalid test result section 26.185(c) section 26.185(c) 26.185(h)(1): Donor discussion with MRO regarding a Burden accounted for under Burden accounted for under Updated -

substituted test result section 26.185(c) section 26.185(c)

Consolidated 26.185(h)(2): MRO notification to licensee that no valid Burden accounted for under section 26.185(c) Consolidated in Table 2 -

(in Table 2) medical explanation presented Consolidated 26.185(h)(3): MRO notification to licensee that valid medical Burden accounted for under section 26.185(c) Consolidated in Table 2 -

(in Table 2) explanation presented 26.185(i)(1): Donor discussion with MRO regarding an Burden accounted for under Burden accounted for under Updated -

adulterated test result section 26.185(c) section 26.185(c)

Consolidated 26.185(i)(2): MRO notification to licensee that no valid Burden accounted for under section 26.185(c) Consolidated in Table 2 -

(in Table 2) medical explanation presented 26.185(i)(3): MRO notification to licensee that valid medical Consolidated explanation presented for an adulterated test result Burden accounted for under section 26.185(c) Consolidated in Table 2 -

(in Table 2) 26.185(j) Donor discussion with MRO regarding a positive test result from use of a prescription medication (amphetamine, morphine, codeine), and donor provides Burden accounted for under Updated documentation on medication use to the MRO (e.g., 60.0 1.0 60.0 60.0 section 26.185(c) prescription information and pharmacy, prescribing physician information)

Consolidated 26.185(k): MRO report to licensee that no FFD policy 24.0 1.0 24.0 Consolidated in Table 2 (24.0)

(in Table 2) violation has occurred 26.185(m): MRO review of inspection and audit reports, quality control data, multiple specimens, and other data to Consolidated determine if positive, adulterated, substituted, or invalid 24.0 1.0 24.0 Consolidated in Table 2 (24.0)

(in Table 2) result is scientifically insufficient for determination of FFD policy violation 26.185(n): Second HHS lab provides the MRO with test Updated result report (for retesting of an aliquot of a single specimen 54.0 1.0 54.0 31.1 0.25 7.8 (46.2) or the testing of a Bottle B split specimen) 26.185(o): HHS lab provides report with quantitative test Duplicative results for a specimen from a donor applying for reauthorization following a 1st positive drug test result (at 8.0 0.5 4.0 Duplicate with row below (4.0)

Burden MRO request) 26.185(o): HHS lab provides quantitation of test results for Duplicative testing performed on a specimen from a donor applying for Burden accounted for under reauthorization following a 1st positive drug test result (at 8.0 1.0 8.0 (8.0)

Burden sections 26.169(c)(1)

MRO request)

Consolidated 26.185(p): MRO notice to licensee of determination of FFD Burden accounted for under section 26.185(c) Consolidated in Table 2 -

(in Table 2) policy violation Consolidated 26.187(d): SAE training requirements 24.0 20.0 480.0 Consolidated in Table 2 (480.0)

(in Table 2)

Consolidated 26.187(f): Documentation of SAE credentials and training 24.0 1.0 24.0 Consolidated in Table 2 (24.0)

(in Table 2) 26.189(b): If a qualified treatment professional other than the MRO or SAE performs a determination of fitness on an Updated individual, that treatment professional completes and 69.0 1.0 69.0 26.0 1.0 26.0 (43.0) provides a written determination to the MRO Consolidated 26.189(c): Written record of a For-cause determination of 6.9 1.0 6.9 Consolidated in Table 2 (6.90)

(in Table 2) fitness Consolidated 26.189(d): Modification of an initial determination of fitness 24.0 1.0 24.0 Consolidated in Table 2 (24.0)

(in Table 2) based on information from other sources 26.209(a): Individual declares that due to fatigue, he or she Updated is unable to safety and competently perform his or her 23.0 0.3 6.9 21.0 0.3 6.3 (0.60) duties 26.405(g): For a reactor construction site FFD program, MRO reports of positive, adulterated, substituted, or invalid Removed Removed drug test results (for a reactor construction site FFD D&A 90.0 1.0 90.0 (90.0)

(This is not third-party burden) testing program) 26.411(b): Applicant provides written consent to the reactor Updated construction site D&A testing program 4,675.0 0.3 1,402.5 6,898.0 0.25 1,724.5 322.00 26.715(a): Documentation of all aspects of HHS lab testing Previously accounted for in Table 2 Burden covered by HHS lab certification NEW process, not specified elsewhere in section 26.715(b) -

as Annualized Burden requirements OMB Clearance No. 0930-0158 Page 20 of 24

FINAL Supporting Statement, 10 CFR Part 26 Table 4: Annual Third-Party Disclosure Approved Clearance Values Extension (approved 11/30/14 - ICR 201407-3150-007) (2017-2020)

Index Key:

- Consolidated Burden

- Duplicative Total Total Estimate Number Burden Burden

- Moved Section Annual Number Annual Change of Hours per Hours per

- New Burden of Responses Burden Responses Response Response

- Removed Hours Hours

- Updated 26.715(b)(1): Retain personnel files on HHS lab staff Previously accounted for in Table 2 Burden covered by HHS lab certification NEW -

as Annualized Burden requirements OMB Clearance No. 0930-0158 26.715(b)(2): Retain HHS lab chain-of-custody documents Previously accounted for in Table 2 NEW 9.0 240.0 2,160.0 2,160.00 as Annualized Burden 26.715(b)(3): Retain HHS lab QA/QC records Previously accounted for in Table 2 Burden covered by HHS lab certification NEW -

as Annualized Burden requirements OMB Clearance No. 0930-0158 26.715(b)(4): Retain HHS lab superseded procedures Previously accounted for in Table 2 NEW 9.0 40.0 360.0 360.00 as Annualized Burden 26.715(b)(5) Retain all test data from HHS lab (including Previously accounted for in Table 2 Burden covered by HHS lab certification NEW calibration curves and any calculations used in determining -

as Annualized Burden requirements OMB Clearance No. 0930-0158 test results) 26.715(b)(6): HHS lab test reports Previously accounted for in Table 2 NEW 9.0 240.00 2,160.0 2,160.00 as Annualized Burden 26.715(b)(7): HHS lab performance testing records Previously accounted for in Table 2 Burden covered by HHS lab certification NEW -

as Annualized Burden requirements OMB Clearance No. 0930-0158 26.719(c): HHS lab provides information to the licensee or Updated other entity on investigation completed on a testing error 6.0 8.0 48.0 8.0 8.0 64.0 16.00 (information for 30-day event report to NRC) 26.821(b): Written agreement between C/Vs and licensees to permit authorized NRC representatives to inspect, copy, or take away copies of C/Vs documents, records, and 5.0 4.0 20.0 5.0 4.0 20.0 -

reports Table 4 Total 410,999.9 303,559.1 441,569.1 492,029.4 188,470.3 62.1%

Page 21 of 24

FINAL Supporting Statement, 10 CFR Part 26 Approved Clearance Values Extension Table 5: Annualized NRC Burden (approved 11/30/14 - ICR 201407-3150-007) (2017-2020)

Burden Index Key: Estimate Burden Burden

- Updated No. Actions/ Total No. Actions/ Total Change NRC ACTION Hours / Hours /

- Consolidated Year Hours Year Hours

- Removed Action Action Updated Review exemption request under section 26.9 2.0 16.0 32.0 - 16.0 - (32.0)

Review FFD policies and procedures under section 26.27(d)

Updated 12.0 8.0 96.0 12.0 8.0 96.0 -

(performed during periodic inspections)

Review records under section 26.75(h) to ensure only appropriate records maintained for a licensee or other entity Updated who administratively withdraws access for initial positive drug 12.0 4.0 48.0 - 4.0 - (48.0) tests for marijuana or cocaine at an LTF (performed during periodic inspections)

Review and evaluate report made under section 26.77(c)

No reports Updated regarding an NRC employee or contractor being unfit for duty - - - 4.0 - -

anticipated Review documentation provided by SAE upon request by Updated 1.0 4.0 4.0 1.0 4.0 4.0 -

NRC under section 26.187(f)

Review and evaluate a 24-hour report made under section Burden accounted for under Consolidated 26.417(b)(1) to the NRC Operations Center regarding a 1.0 16.0 16.0 (16.0) section 26.719(b) significant FFD program failure Annual FFD program performance report -

Review, analyze, and summarize information received under Updated 2.0 25.0 50.0 2.0 25.0 50.0 -

26.417(b)(2) from a reactor construction site D&A testing program.

Annual fatigue management performance report --

Review, analyze, and summarize fatigue management data Updated specified in section 26.201(e) that is submitted under section 62.0 10.0 620.0 59.0 10.0 590.0 (30.0) 26.717 Annual FFD program performance report -

Updated Review, analyze, and summarize information received under 65.0 25.0 1,625.0 67.0 12.0 804.0 (821.0) 26.717 from a D&A testing program Review reports under section 26.719(a) of significant Burden reported under Removed violations of FFD policy, D&A testing program failures, and REMOVED -

section 26.719 (b) and (c) errors in laboratory testing Page 22 of 24

FINAL Supporting Statement, 10 CFR Part 26 Approved Clearance Values Extension Table 5: Annualized NRC Burden (approved 11/30/14 - ICR 201407-3150-007) (2017-2020)

Burden Index Key: Estimate Burden Burden

- Updated No. Actions/ Total No. Actions/ Total Change NRC ACTION Hours / Hours /

- Consolidated Year Hours Year Hours

- Removed Action Action 24-hour report -- Review, evaluate, and respond to a report made under section 26.719(b) to the NRC Operations Center Updated 37.0 16.0 592.0 37.0 8.0 296.0 (296.0) regarding a significant FFD policy violation or programmatic failure 30-day report -- Review, evaluate, and respond to a report made under section 26.719(c) to the NRC detailing the Updated investigation of any testing errors or unsatisfactory 6.0 4.0 24.0 8.0 4.0 32.0 8.0 performance discovered at an LTF or HHS lab.

Table 5 Total 200.0 3,107.0 186.0 1,872.0 (1,235.0)

-39.7%

Page 23 of 24

FINAL Supporting Statement, 10 CFR Part 26 Summary of Estimated Burden Hours and Costs (2017-2020) 2014-2017 2017-2020 Annualized Cost at Annualized Annualized Change Change Table Description Responses Burden Hours $265/hour Burden Burden Hours  %

1 Recordkeeping (One-Time) - 112.0 $ 29,680 41.4 112.0 70.6 170.5%

2 Recordkeeping (Annual) 49.0 220,886.5 $ 58,534,918 314,177.4 220,886.5 (93,290.9) -29.7%

3 Annual Reporting 215.0 6,168.0 $ 1,634,520 6,165.2 6,168.0 2.8 0.0%

4 Third Party Disclosure (Annual) 441,569.1 492,029.4 $ 130,387,785 303,559.1 492,029.4 188,470.3 62.1%

TOTAL 441,833.1 719,195.9 $ 190,586,904 623,943.1 719,195.9 95,252.8 15.3%

Tables 1 + 2 + 4 Burden >>> 713,027.9 Records storage costs >>> $ 75,580.95 Annualized Cost at Table Description Actions Burden Hours $265/hour 5 NRC Action 186.0 1,872.0 $ 496,080 Page 24 of 24

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